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Kit Static PKSBPHA0226V1

by Surgecare

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 Number03770031522020 UDI-DI Date9 Sep 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  • Withdrawn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
Kit Static
Generic Name
General specimen collection kit IVD, clinical
Catalog Number
PKSBPHA0226V1
Primary DI / UDI-DI
03770031522020
FDA Product Code
OIB
GMDN Term
General specimen collection kit IVD, clinical
Device Class
Class I
Regulation Number
864.3250
GUDID distribution status
In Commercial Distribution

Properties

  • Single Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No