Identity
- Trade Name
- Avitene FDA UDI
- Generic Name
- Collagen haemostatic agent, non-antimicrobial FDA UDI
- Device Name
- EndoAvitene Microfibrillar Collagen Hemostat in an Endoscopic Delivery System FDA UDI
- Model / Reference
- 1010260 FDA UDI
- Description
- EndoAvitene Microfibrillar Collagen Hemostat in an Endoscopic Delivery System FDA UDI
Identifiers
- Catalog Number
- 1010260 FDA UDI
- Primary DI / UDI-DI
- 00801741010491 FDA UDI
- PMA Number
- P800002 FDA UDI
- FDA Product Code
- LMF FDA UDI
- GMDN Term
- Collagen haemostatic agent, non-antimicrobial FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 878.4490 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 50 Millimeter FDA UDIOuter Diameter — 5 Millimeter FDA UDIWidth — 5 Millimeter FDA UDIDepth — 1 Millimeter FDA UDI
Avitene by Davol Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P800002 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 III | Pending data |
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Manufacturer
- Manufacturer
- Davol Inc.
Sources (1)
- FDA UDI a36f8543-1056-49b2-b29d-fb802b9fc76c 38 fields · synced Jun 7, 2026