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ORCA Foam Powder OF-PS-06

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850056665292 UDI-DI Date30 Sep 2025ListedStatusListed 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  • Withdrawn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 Powder
Generic Name
Gelatin haemostatic agent
Model / Reference
OF-PS-06
Primary DI / UDI-DI
00850056665292
FDA Product Code
KHJ
GMDN Term
Gelatin haemostatic agent
Device Class
Class II
Regulation Number
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