Identity
- Trade Name
- Gelseal™ FDA UDI
- Generic Name
- Synthetic vascular graft FDA UDI
- Device Name
- Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT FDA UDI
- Model / Reference
- 431034 FDA UDI
- Description
- Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT FDA UDI
Identifiers
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 34 Millimeter FDA UDILength — 10 Centimeter FDA UDI
Category: Synthetic vascular graft
Gelseal™ by Vascutek Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic vascular graft.
- GORE PROPATEN Vascular Graft Pediatric Shunt — W. L. GORE & ASSOCIATES, INC · Class II
- COOK — William Cook Europe ApS · Class III
- Zenith — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class III
- ADVANTA SLIDER GDS — Atrium Medical Corp. · Class II
- IMPRA® ePTFE Vascular Grafts — Bard Peripheral Vascular · Class II
- Zenith — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class III
- Hemashield — Intervascular, Inc. · Class II
- Zenith Alpha — William Cook Europe ApS · Class III
Cleared under the same submission
K162803 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vascutek Ltd
Sources (1)
- FDA UDI b455e81d-4cf7-44cb-929c-c0e4288e7201 38 fields · synced May 30, 2026