Identity
- Trade Name
- ORCA Foam FDA UDI
- Generic Name
- Gelatin haemostatic agent FDA UDI
- Device Name
- AbsorbaleGelatin Sponge FDA UDI
- Model / Reference
- Sze 100 FDA UDI
- Description
- AbsorbaleGelatin Sponge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10860003109998 FDA UDI
- 510(k) Number
- K060878 FDA UDI
- FDA Product Code
- LYA FDA UDIKHA FDA UDI
- GMDN Term
- Gelatin haemostatic agent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4780 FDA UDI868.5590 FDA UDI
- Commercial Distribution
- Not 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
ORCA Foam by Orca Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Orca Products Llc
Sources (1)
- FDA UDI 30bc6591-9055-4c0f-b045-2af27756b041 35 fields · synced May 30, 2026