Avitene

FDA UDI

Class III (US FDA UDI)

by Davol Inc.

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: 1010150 FDA UDI
Description: EndoAvitene Microfibrillar Collagen Hemostat in an Endoscopic Delivery System FDA UDI

Identifiers

Catalog Number: 1010150 FDA UDI
Primary DI / UDI-DI: 00801741010484 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 15 Millimeter FDA UDI
Outer Diameter — 10 Millimeter FDA UDI
Depth — 1 Millimeter FDA UDI
Length — 50 Millimeter FDA UDI

Category: Collagen haemostatic agent, non-antimicrobial

Avitene by Davol Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Collagen haemostatic agent, non-antimicrobial.

D-Stat® Flowable Hemostat — Vascular Solutions, Inc. · U
Floseal — Baxter Healthcare Corp · Class III
Floseal Hemostatic Matrix — Baxter Healthcare Corp · Class III
Helistat® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE — Integra Lifesciences Corp. · Class III
FLOSEAL HEMOSTATIC MATRIX — Baxter Healthcare Corp · Class III
Floseal Special Applicator Tips — Baxter Healthcare Corp · Class III
Simpurity — SAFE N SIMPLE LLC · Class I
D-STAT — TELEFLEX INCORPORATED · Class III

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 1004162e-f3af-42ca-b166-a8e2ac5a317d 38 fields · synced May 31, 2026