Catalogue values for Endobags (V2)
| Category | Specification | Bid Requirement (Allowed Values) |
|---|---|---|
| GENERAL | Product Description | Endobag |
| Usage | Single-Use (Disposable) | |
| Sterility | Sterile | |
| PRODUCT INFORMATION | Introducer trocar Size (Diameter) | 10 mm |
| Material of bag | Medical Grade Thermoplastic Polyurethane (TPU) | |
| Tear Resistant | Yes | |
| Maximum specimen size (Diameter) | 50 mm | |
| Bag Capacity (±5ml) | 500 mL | |
| CERTIFICATIONS AND 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 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 | |
| SHELF LIFE | Shelf Life from the date of manufacture (in months) | 36 Or higher |
| Minimum shelf life of the product at the time of delivery to the consignee | 3/4 th of Total Shelf Life | |
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