QSL Package Worksheet MS-2310-84 LAPARASCOPIC TROCARS.xlsx

XLSX spreadsheet 18 KB Posted May 31, 2024

Attached to: LAPAROSCOPIC TROCARS
Solicitation number: MS-2310-84
Issued by: Defense Logistics Agency Troop Support Medical

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Written by GovTribe AI · May 31, 2024

This document is a Sources Sought notification for the creation of a Qualified Suppliers Listing (QSL) for Laparoscopic Trocars. The Defense Health Agency (DHA) Medical Logistics (MEDLOG) Division, Medical Materiel Enterprise Standardization Office (MMESO), and the Defense Logistics Agency (DLA) Troop Support Medical Prime Vendor Program are seeking vendors to provide various Laparoscopic Trocars products. The estimated annual sales volume for these products is $1,955,146. Six required items account for 89.10% of this volume. Vendors must meet specific requirements such as having a DAPA number, agreements with the current DoD Medical/Surgical Prime Vendors, an active SAM registration, and providing documentation on product characteristics. Vendors may also offer optional Laparoscopic Trocars items. Responses to the Sources Sought notification are due by 5:00 pm local Philadelphia time on June 20, 2024. The QSL for Laparoscopic Trocars is anticipated to be established around August 20, 2024 and may lead to a subsequent Standardization Action.

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QSL Announcement MS-2310-84 LAPAROSCOPIC TROCARS.docx	DOCX document	May 31, 2024

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QSL Package Worksheet

Requirements to Qualify for the QSL	MS-2310-84 LAPARASCOPIC TROCARS
Company Name:
Company Address:
Company Point of Contact (POC):

Name Phone Number E-Mail Address

****PLEASE READ THE FOLLOWING BEFORE CONTINUING WITH YOUR SUBMISSION BELOW***

Product requirements are outlined below. Complete answers and all supporting documentation MUST be provided with the vendor’s submittal by the response date stated in the Sources Sought notification. A vendor who does not meet all of these requirements or who does not submit documentation to support these requirements as requested will not be qualified for the QSL. Vendor must provide responses to the Sources Sought notification via the QSL Package Worksheet.

SUPPLIER REQUIREMENTS

VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" ENTER YOUR DAPA NUMBER OR THE DATE YOU APPLIED FOR A DAPA ALONG WITH DAPA LOG NUMBER.

1. Vendor must have a DAPA or be in the process of applying for a DAPA number for the product line listed. Vendor must provide their DAPA number or provide date of application and DMM number proving access to the DMS, as the subsequent Standardization Action requires vendors to have all required items on DAPA.	VENDOR RESPONSE:
VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" ENTER

YES - IF YOU HAVE AN AGREEMENT

NO - IF YOU DO NOT HAVE AN AGREEMENT AND INDICATE THAT YOU ARE WORKING WITH PRIME VENDOR TO INITIATE AN AGREEMENT.

2. Vendor must have an agreement with the current DoD Medical/Surgical Prime Vendor CARDINAL HEALTH, or must work with CARDINAL HEALTH to initiate an agreement, as standardized items from this QSL will be distributed via the MSPV program.	VENDOR RESPONSE:
3. Vendor must have an agreement with the current DoD Medical/Surgical Prime Vendor OWENS & MINOR, or must work with OWENS & MINOR to initiate an agreement, as standardized items from this QSL will be distributed via the MSPV program.	VENDOR RESPONSE:
VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" ENTER YOUR CAGE CODE OR THE DATE YOU APPLIED FOR A CAGE CODE ALONG WITH THE CURRENT STATUS.

4. Vendors must validate that their account is Active in the System for Award Management (SAM) and provide CAGE Code. Vendors in the process of obtaining a CAGE Code must provide documentation to support that they have registered in SAM. Vendors without a CAGE Code and/or a SAM account will not be considered for participation in the subsequent Standardization Action. See https://www.sam.gov/SAM/.	VENDOR RESPONSE:
REQUIRED PRODUCTS
VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" for EACH REQUIRED ITEM IDENTIFY SUPPORTING DOCUMENTATION(S) (i.e. catalogs, brochures, website screen shots with date, product pictures, packaging pictures, etc.). WITHIN DOCUMENTATION, ANNOTATE SECTION(S) THAT SUPPORT SPECIFIC REQUIREMENT.

5. Vendor must provide manufacturer part numbers that meet the product descriptions below. Vendor must submit the following information via QSL Response Worksheet for each offered product: Vendor Part Number, Manufacturer Part Number, Manufacturer Name, Full Item Description, Unit of Measure (UOM), Quantity (QTY) in UOM, Unit of Inner Packaging (UOP), QTY of UOM in UOP, Unit of Sale (UOS), and QTY of UOM in UOS. Vendor must provide product catalog and literature for any items offered in response to this Sources Sought notification. Only ONE Vendor Part Number should be provided for each item/sample. Vendor must send the same reference number(s) for evaluation(s) as provided in response to this QSL Announcement and as noted in the QSL Package Worksheet. The vendor must provide country of origin for all required items and any optional items offered.

Required Product Description

Estimated DoD Purchase Units

Manufacturer's Product Description

Manufacturer Part Number

Distributor Part Number

Manufacturer Name

Unit of Measure (UOM)

QTY in UOM

Unit of Inner Packaging (UOP)

QTY of UOM in UOP

Unit of Sale (UOS)

QTY of UOM in UOS

Product Country of Origin

Vendor Response

E.g. 0 12-18in COATED VICRYL VIO BRD TIES

Z123-ABC

123ABC

COMPANY A

USA

See Product Catalog pg. 109

5.1 LAPAROSCOPIC TROCARS, 12MM DIAMETER BY 100MM LENGTH, WITH FIXATION/STABILITY SLEEVE AND BLADELESS OBTURATOR WITH OPTICAL TIP

10,692

5.2 LAPAROSCOPIC TROCARS, 15MM DIAMETER BY 100MM LENGTH, WITH FIXATION/STABILITY SLEEVE AND BLADELESS OBTURATOR WITH OPTICAL TIP

916

5.3 LAPAROSCOPIC TROCARS, 5MM DIAMETER BY 100MM LENGTH, WITH FIXATION/STABILITY CANNULA

3,174

5.4 LAPAROSCOPIC TROCARS, 5MM DIAMETER BY 100MM LENGTH, WITH FIXATION/STABILITY SLEEVE AND BLADELESS OBTURATOR WITH OPTICAL TIP

11,160

5.5 LAPAROSCOPIC TROCARS, 5MM DIAMETER BY 150MM LENGTH, WITH FIXATION/STABILITY SLEEVE AND BLADELESS OBTURATOR WITH OPTICAL TIP

642

5.6 LAPAROSCOPIC TROCARS, 5MM DIAMETER BY 75MM LENGTH, WITH FIXATION/STABILITY SLEEVE AND BLADELESS OBTURATOR WITH OPTICAL TIP

1,914

PRODUCT SPECIFIC REQUIREMENTS - TECHNICAL REVIEW

VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" IDENTIFY SUPPORTING DOCUMENTATION(S) (i.e. catalogs, brochures, website screen shots with date, product pictures, packaging pictures, etc.). WITHIN DOCUMENTATION, ANNOTATE SECTION(S) THAT SUPPORT SPECIFIC REQUIREMENT.

E.g. See ENCL 3 - Suture + Ties Reels Memo Natural Rubber Latex

6. Vendor must provide Laparoscopic Trocars products that are not made with natural rubber latex. Vendor must also provide submittal documentation establishing that the offered products are not made with natural rubber latex. The vendor must meet this requirement in one of three ways: 1) demonstrating that the labeling or product information for the offered products contains the FDA recommended statement "Not made with natural rubber latex," 2) demonstrating that the ISO BS EN 15223-1:2016 symbol [reference number 5.4.5 with Annex B.2 Negation Symbol] is on the labeling or product information for the offered products, or 3) if the labeling or product information do not contain the FDA recommended statement or the ISO BS EN 15223-1:2016 symbol [reference number 5.4.5 with Annex B.2 Negation Symbol], the vendor must provide a signed letter stating that the offered products are "not made with natural rubber latex."	6	Vendor must provide Laparoscopic Trocars products that are not made with natural rubber latex. Vendor must also provide submittal documentation establishing that the offered products are not made with natural rubber latex. The vendor must meet this requirement in one of three ways: 1) demonstrating that the labeling or product information for the offered products contains the FDA recommended statement "Not made with natural rubber latex," 2) demonstrating that the ISO BS EN 15223-1:2016 symbol [reference number 5.4.5 with Annex B.2 Negation Symbol] is on the labeling or product information for the offered products, or 3) if the labeling or product information do not contain the FDA recommended statement or the ISO BS EN 15223-1:2016 symbol [reference number 5.4.5 with Annex B.2 Negation Symbol], the vendor must provide a signed letter stating that the offered products are "not made with natural rubber latex."	6	16	VENDOR RESPONSE:
VENDOR INSTRUCTIONS

Vendor must provide photographic images of required item 5.4 in support of requirements #8, 9, 10, 11 & 12. For individual product packaging, vendor must submit a legible photograph of front and back of product’s individual package. Graphic templates of product labeling are NOT ACCEPTABLE supporting documentation. Vendor must provide a letter of attestation, including a list of part numbers for the required items 5.1-5.3, and 5.5-5.6, stating that the offered products meet requirements #8, 9, 10, 11 & 12

	7. Vendor must provide Laparoscopic Trocar products that are cleared by the FDA through Class II Medical Devices and provide the FDA 510(k) to support this with initial submittal.	7	Vendor must provide Laparoscopic Trocar products that are cleared by the FDA through Class II Medical Devices and provide the FDA 510(k) to support this with initial submittal.	7	Vendor must provide photographic images of required item 5.4 in support of requirements #8, 9, 10, 11 & 12. For individual product packaging, vendor must submit a legible photograph of front and back of product’s individual package. Graphic templates of product labeling are NOT ACCEPTABLE supporting documentation. Vendor must provide a letter of attestation, including a list of part numbers for the required items 5.1-5.3, and 5.5-5.6, stating that the offered products meet requirements #8, 9, 10, 11 & 12	17		VENDOR RESPONSE:
	8. Vendor must provide Laparoscopic Trocars products that indicate on the product box packaging the following:
a.	Trocar Type
b.	Trocar Size
c.	Quantity/Box
d.	Bar Code, QR Code, Re-order Code, or Part number	8	Vendor must provide Laparoscopic Trocars products that indicate on the product box packaging the following:
a.	Trocar Type
b.	Trocar Size
c.	Quantity/Box
d.	Bar Code, QR Code, Re-order Code, or Part numbe	8		18			VENDOR RESPONSE:
	9. Vendor must provide Laparoscopic Trocars products that indicate on the individual product packaging the following:
a.	Trocar Type
b.	Trocar Size
c.	Lot Number in a statement or with the appropriate ISO BS EN ISO 15223-1:2016 lot number symbol
d.	Expiration/Use by date in a statement or with the appropriate ISO BS EN ISO 15223-1:2016 Use by date symbol
e.	Bar Code, QR Code, Re-order Code, and/or Part number	9	Vendor must provide Laparoscopic Trocars products that indicate on the individual product packaging the following:
a.	Trocar Type
b.	Trocar Size
c.	Lot Number in a statement or with the appropriate ISO BS EN ISO 15223-1:2016 lot number symbol
d.	Expiration/Use by date in a statement or with the appropriate ISO BS EN ISO 15223-1:2016 Use by date symbol
e.	Bar Code, QR Code, Re-order Code, and/or Part numbe	9		19			VENDOR RESPONSE:
	10. Vendor must provide Laparoscopic Trocars products that are single-use items. The vendor must meet this requirement in one of two ways: 1) demonstrating that the labeling or product information for the offered products contains the recommended statement "single use,” "use only once,” “do not re-use,” or “do not resterilize,” or 2) demonstrating that the ISO BS EN 15223-1:2016 single-use symbol is on the labeling or product information for the offered products.	10	Vendor must provide Laparoscopic Trocars products that are single-use items. The vendor must meet this requirement in one of two ways: 1) demonstrating that the labeling or product information for the offered products contains the recommended statement "single use”, "use only once”, “do not re-use” or “do not resterilize”, or 2) demonstrating that the ISO BS EN 15223-1:2016 single-use symbol is on the labeling or product information for the offered products.	10		110		VENDOR RESPONSE:
	11. Vendor must provide Laparoscopic Trocars products that are packaged with an overwrap (e.g., peel package/Blister Pack) to facilitate aseptic presentation to a sterile field and provide appropriate supporting documentation with initial submittal.	11	Vendor must provide Laparoscopic Trocars products that are packaged with an overwrap (e.g., peel package/Blister Pack) to facilitate aseptic presentation to a sterile field and provide appropriate supporting documentation with initial submittal.	11		111		VENDOR RESPONSE:
	12. Vendor must provide Laparoscopic Trocars products with packaged contents that are sterile and indicated as such on the individual product packaging; whether in printed language or by an accepted ISO BS EN ISO 15223-1: 2016 sterile symbol [reference number 5.4.2]. Vendor must provide appropriate supporting documentation with initial submittal.	12	Vendor must provide Laparoscopic Trocars products with packaged contents that are sterile and indicated as such on the individual product packaging; whether in printed language or by an accepted ISO BS EN ISO 15223-1: 2016 sterile symbol [reference number 5.4.2]. Vendor must provide appropriate supporting documentation with initial submittal.	12		112		VENDOR RESPONSE:
	13. Vendor must provide Laparoscopic Trocars with a Pneumatic Inlet port with stopcock and provide appropriate supporting documentation with initial submittal.	13	Vendor must provide Laparoscopic Trocars with a Pneumatic Inlet port with stopcock and provide appropriate supporting documentation with initial submittal.	13		113		VENDOR RESPONSE:
	14. Vendor must provide Laparoscopic Trocars with a Pneumatic seal and provide appropriate supporting documentation with initial submittal.	14	Vendor must provide Laparoscopic Trocars with a Pneumatic seal and provide appropriate supporting documentation with initial submittal.	14		114		VENDOR RESPONSE:
	15. Vendor must provide Laparoscopic Trocars with an Obturator release button and provide appropriate supporting documentation with initial submittal.	15	Vendor must provide Laparoscopic Trocars with an Obturator release button and provide appropriate supporting documentation with initial submittal.	15		115		VENDOR RESPONSE:
	VENDOR INSTRUCTIONS

Vendor MAY provide any or all of the additional items listed below following the same format as for Requirement number 5.

Vendor must provide a letter of attestation, INCLUDING a list of part numbers for the submitted optional items, stating that the offered products meet all requirements after requirement 6.

Item Descriptions

Estimated DoD Purchase Units

Manufacturer's Product Description

Manufacturer Part Number

Distributor Part Number

Manufacturer Name

Unit of Measure (UOM)

QTY in UOM

Unit of Inner Packaging (UOP)

QTY of UOM in UOP

Unit of Sale (UOS)

QTY of UOM in UOS

Product Country of Origin

Vendor Response

E.g. 0 12-18in COATED VICRYL VIO BRD TIES

Z123-ABC

123ABC

COMPANY A

USA

See Product Catalog pg. 109

1. LAPAROSCOPIC TROCARS, 12MM DIAMETER CONVERTER BALLON AND BLUNT TIP OBTURATOR WITH 5MM and 10MM CONVETERS

2. LAPAROSCOPIC TROCARS, 12MM DIAMETER BY 150MM LENGTH, WITH FIXATION/STABILITY SLEEVE AND BLADELESS OBTURATOR WITH OPTICAL TIP

3. LAPAROSCOPIC TROCARS, 5MM DIAMETER DISSECTION BALLON AND BLUNT TIP LOW PROFILE OPTICAL TIP

4. LAPAROSCOPIC TROCARS, 5MM DIAMETER STRUCTURAL DISSECTION BALLON AND BLUNT TIP LOW PROFILE OPTICAL TIP

5. LAPAROSCOPIC TROCARS, 5MM DIAMETER BY 100MM LENGTH, WITH FIXATION/STABILITY SLEEVE AND BLADLESS OBTURATOR

6. LAPAROSCOPIC TROCARS, 5MM DIAMETER BY 75MM LENGTH, WITH FIXATION/STABILITY CANNULA

7. LAPAROSCOPIC TROCARS, 5MM DIAMETER BY 75MM LENGTH, WITH FIXATION/STABILITY SLEEVE AND BLADELESS OBTURATOR

File details come from the government source that posted it. Updated May 31, 2024.