Identity
- Trade Name
- FLOSEAL HEMOSTATIC MATRIX FDA UDI
- Generic Name
- Collagen haemostatic agent, non-antimicrobial FDA UDI
- Device Name
- Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. FDA UDI
- Model / Reference
- ADS201883 FDA UDI
- Description
- Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. FDA UDI
Identifiers
- Catalog Number
- ADS201883 FDA UDI
- Primary DI / UDI-DI
- 00085412656304 FDA UDI
- PMA Number
- P990009 FDA UDI
- FDA Product Code
- PMX 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
- Total Volume — 5 Milliliter FDA UDI
Category: Collagen haemostatic agent, non-antimicrobial
Floseal Hemostatic Matrix by Baxter Healthcare Corp — 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
- Avitene — Davol Inc. · Class III
- Helistat® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE — Integra Lifesciences Corp. · Class III
- Simpurity — SAFE N SIMPLE LLC · Class I
- D-STAT — TELEFLEX INCORPORATED · Class III
- Gelfoam — Pharmacia & Upjohn Co. · Class III
- Avitene — Davol Inc. · Class III
- Simpurity — SAFE N SIMPLE LLC · Class I
Cleared under the same submission
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
- Baxter Healthcare Corp
Sources (1)
- FDA UDI 50bb92ba-a4cf-4166-848d-839427ce9717 38 fields · synced May 31, 2026