GeM | Bidding

Category	Specification	Bid Requirement (Allowed Values)
General Features	Product Description	Detachable Surgical Blades (Bard Parker Type)
Conformity to Standard	Conformity to Standard	IS 3319 (Latest)
ISI Marked	Yes
Technical Features	Sterile Blades	Yes
Disposable Blade	Yes
Commercial Designation of Blades	15
Dimensions, Material & Construction	Material of Blade	Stainless Steel
Thickness of Blades	0.4, 0.41
Dimensions of blades for small & large size fittings shall be as per IS 3319 (Latest)	Yes
Packing	Packaging & Marking shall be as per IS 3319 (Latest)	Yes
Certifications & Reports	Compliance to Medical Device Rule (MDR) 2017 as amended till date	Yes
Availability of valid drug license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date	Yes
Manufacturing unit certification	ISO: 13485 (Latest)
Availability of Test Report for each supplied batch/product from CDSCO approved Laboratory as per Medical Device Rule (MDR) 2017 as amended till date	Yes
Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement	Yes

Category

Specification

Bid Requirement (Allowed Values)

General Features

Product Description

Detachable Surgical Blades (Bard Parker Type)

Conformity to Standard

IS 3319 (Latest)

ISI Marked

Yes

Technical Features

Sterile Blades

Yes

Disposable Blade

Yes

Commercial Designation of Blades

Dimensions, Material & Construction

Material of Blade

Stainless Steel

Thickness of Blades

0.4, 0.41

Dimensions of blades for small & large size fittings shall be as per IS 3319 (Latest)

Yes

Packing

Packaging & Marking shall be as per IS 3319 (Latest)

Yes

Certifications & Reports

Compliance to Medical Device Rule (MDR) 2017 as amended till date

Yes

Availability of valid drug license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date

Yes

Manufacturing unit certification

ISO: 13485 (Latest)

Availability of Test Report for each supplied batch/product from CDSCO approved Laboratory as per Medical Device Rule (MDR) 2017 as amended till date

Yes

Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement

Yes