Identity
- Trade Name
- AlboGraft Polyester Vascular Graft FDA UDI
- Generic Name
- Synthetic vascular graft FDA UDI
- Device Name
- AlboGraft® Knitted with Collagen 16mm x 40cm FDA UDI
- Model / Reference
- AMC4016 FDA UDI
- Description
- AlboGraft® Knitted with Collagen 16mm x 40cm FDA UDI
Identifiers
- Catalog Number
- AMC4016 FDA UDI
- Primary DI / UDI-DI
- 00840663110407 FDA UDI
- FDA Product Code
- MAL FDA UDI
- GMDN Term
- Synthetic vascular graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3450 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
MR Safe FDA UDI
AlboGraft Polyester Vascular Graft by LeMaitre Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- LeMaitre Vascular, Inc.
Sources (1)
- FDA UDI 29cfa18d-f39e-42ee-92bd-2f92a7dc406d 37 fields · synced Jun 9, 2026