Avitene 1010080
by Davol Inc.
Avitene 1010080 is a Class III device made by Davol Inc., approved under FDA PMA P800002 on 28 Jan 1982 and listed in FDA GUDID since 12 Sep 2014 (UDI-DI 00801741010453), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00801741010453 | Date12 Sep 2014 | StatusListed |
| United States | FDA PMAAPPR | NumberP800002 | Date28 Jan 1982 | StatusActive |
Official records
- AccessGUDID record 00801741010453
- FDA PMA database P800002
Across registries
- FDA PMA P800002 decided 28 Jan 1982 Active
- FDA GUDID UDI-DI 00801741010453 listed 12 Sep 2014 Listed
Timeline
- Approved FDA PMA P800002
- Listed FDA GUDID 00801741010453
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Avitene
- Generic name
- Collagen haemostatic agent, non-antimicrobial
- Model / Ref / Catalog
- 1010080
- Primary DI / UDI-DI
- 00801741010453
- PMA number
- FDA product code
- LMF
- GMDN term
- Collagen haemostatic agent, non-antimicrobial
- Device class
- Class III
- Regulation number
- 878.4490
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 35 MillimeterWidth — 35 MillimeterDepth — 1 Millimeter
Similar devices
Other devices filed under FDA product code LMF (Agent, absorbable hemostatic, collagen based).
- Novacol Textured Collagen Hemostatic Agent by Datascope Corp.
- Surgifoam Absorbable Gelatin Sponge by Ferrosan Meidcal Devices A/S
- Helitene® 1692-ZL by Integra Lifesciences Corp.
- AVITENE MICROFIBIBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR, 1G SYRINGE, ENDO AVIETENE by C. R. Bard, Inc.
- Gelfoam Sterile Sponge by PFIZER INC.
- Avitene Ultra Foam Cast Microfibrillar Collagen Hemostat Sponge by Davol Inc., Sub. C. R. Bard, Inc.
- Helitene® 1692-ZK by Integra Lifesciences Corp.
- Superstat Absorbable Hemostatic Collagen Agent by Superstat Corp.
- Actifoam Absorbable Collagen Hemostatic Sponge by Coletica S.A.
- Collastat Absorbable Collagen Hemostatic Agent by Integra Lifesciences Corporation