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ORCA Foam

FDA UDI

Class I (US FDA UDI)

by Orca Products Llc

Identity

Trade Name
ORCA Foam FDA UDI
Generic Name
Gelatin haemostatic agent FDA UDI
Device Name
AbsorbaleGelatin Sponge FDA UDI
Model / Reference
Size 4 FDA UDI
Description
AbsorbaleGelatin Sponge FDA UDI

Identifiers

Primary DI / UDI-DI
00860008294333 FDA UDI
FDA Product Code
LYA FDA UDI
KHJ FDA UDI
GMDN Term
Gelatin haemostatic agent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4780 FDA UDI
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 I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gelatin haemostatic agent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orca Products Llc

Sources (1)

  • FDA UDI 2d48b730-fd8b-48fb-8fce-5c22bba812ce 34 fields · synced Jun 1, 2026