Identity
- Trade Name
- ORCA Foam FDA UDI
- Generic Name
- Gelatin haemostatic agent FDA UDI
- Device Name
- AbsorbaleGelatin Sponge (80mm x 30mm cylinder) FDA UDI
- Model / Reference
- OF-8030 FDA UDI
- Description
- AbsorbaleGelatin Sponge (80mm x 30mm cylinder) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850056665223 FDA UDI
- FDA Product Code
- KHJ FDA UDI
- GMDN Term
- Gelatin haemostatic agent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3620 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gelatin haemostatic agent
ORCA Foam by Orca Products Llc — Class II — 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
- 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
- OSSEOUS Gelatin Sponge Nasal — EON MEDITECH PRIVATE LIMITED · Class I
- SURGIFLO® Hemostatic Matrix — Ferrosan Medical Devices A/S · Class III
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 II | Pending data |
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Manufacturer
- Manufacturer
- Orca Products Llc
Sources (1)
- FDA UDI d2d7aac1-52fd-4d1f-bd27-75b95d0e84bb 34 fields · synced Jun 8, 2026