Identity
- Trade Name
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. FDA UDI
- Generic Name
- Gelatin haemostatic agent FDA UDI
- Model / Reference
- 1974 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15712123000189 FDA UDI
- PMA Number
- P990004 FDA UDI
- FDA Product Code
- LMF FDA UDI
- GMDN Term
- Gelatin haemostatic agent 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
No
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
- Area/Surface Area — 100 Square centimeter FDA UDI
Category: Gelatin haemostatic agent
SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. by Ferrosan Medical Devices A/S — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gelatin haemostatic agent.
- OSSEOUS Gelatin Sponge — EON MEDITECH PRIVATE LIMITED · Class I
- OSSEOUS Gelatin Sponge Unilateral — EON MEDITECH PRIVATE LIMITED · Class I
- ORCA Foam — ORCA PRODUCTS LLC · Class I
- ORCA Foam — ORCA PRODUCTS LLC · Class I
- OSSEOUS Gelatin Sponge — EON MEDITECH PRIVATE LIMITED · Class I
- OSSEOUS Gelatin Sponge Film — EON MEDITECH PRIVATE LIMITED · Class I
- OSSEOUS Gelatin Sponge — EON MEDITECH PRIVATE LIMITED · Class I
- OSSEOUS Gelatin Sponge — EON MEDITECH PRIVATE LIMITED · Class I
Cleared under the same submission
P990004 also covers:
- SURGIFLO® Hemostatic Matrix — Ferrosan Medical Devices A/S
- SURGIFLO® Hemostatic Matrix Kit with Thrombin — Ferrosan Medical Devices A/S
- SURGIFOAM® Absorbable Gelatin Powder — Ferrosan Medical Devices A/S
- SURGIFOAM® Absorbable Gelatin Powder Kit — Ferrosan Medical Devices A/S
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. — Ferrosan Medical Devices A/S
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. — Ferrosan Medical Devices A/S
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. — Ferrosan Medical Devices A/S
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Hemorrhoidectomy Sponge — Ferrosan Medical Devices A/S
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Oral Sponge — Ferrosan Medical Devices A/S
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
- Ferrosan Medical Devices A/S
Sources (1)
- FDA UDI 1da0c298-8e5b-4330-ab0b-1795a9138888 35 fields · synced May 30, 2026