Identity
- Trade Name
- Gelfoam FDA UDI
- Generic Name
- Collagen haemostatic agent, non-antimicrobial FDA UDI
- Device Name
- Absorbable Hemostatic Sponge, Collagen Based FDA UDI
- Model / Reference
- Size 50 FDA UDI
- Description
- Absorbable Hemostatic Sponge, Collagen Based FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10300090323018 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
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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Height — 10 Millimeter FDA UDILength — 80 Millimeter FDA UDIWidth — 62.5 Millimeter FDA UDI
Category: Collagen haemostatic agent, non-antimicrobial
Gelfoam by Pharmacia & Upjohn Co. — 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
- Avitene — Davol Inc. · 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
Cleared under the same submission
N18286 also covers:
- GEL-FLOW KIT — Pharmacia & Upjohn Co.
- GEL-FLOW™ NT — Pharmacia & Upjohn Co.
- GELFOAM-JMI™ Powder Kit — Pharmacia & Upjohn Co.
- GELFOAM-JMI™ Sponge Kit — Pharmacia & Upjohn Co.
- Gelfoam — Pharmacia & Upjohn Co.
- Gelfoam — Pharmacia & Upjohn Co.
- Gelfoam — Pharmacia & Upjohn Co.
- Gelfoam — Pharmacia & Upjohn Co.
- Gelfoam — Pharmacia & Upjohn Co.
- Gelfoam — Pharmacia & Upjohn Co.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pharmacia & Upjohn Co.
Sources (1)
- FDA UDI 995d6538-5d93-441b-8317-1c490127e82a 37 fields · synced May 30, 2026