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ORCA Foam OF-401010

by Orca Products LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10850056665305 UDI-DI Date7 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ORCA Foam
Generic Name
Gelatin haemostatic agent
Model / Reference
OF-401010
Primary DI / UDI-DI
10850056665305
FDA Product Code
LYA, KHJ
GMDN Term
Gelatin haemostatic agent
Device Class
Class I
Regulation Number
874.4780, 874.3620
GUDID distribution status
In Commercial Distribution

Other devices from Orca Products LLC

See all devices from Orca Products LLC →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No