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HRA Convenience Procedure Kit 1.0

by Bucher Medical Enterprise 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 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00199874049274 UDI-DI Date23 Oct 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  • Withdrawn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
HRA Convenience Procedure Kit
Generic name
General surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
1.0, BME-HRAKIT
Primary DI / UDI-DI
00199874049274
FDA product code
PSJ
GMDN term
General surgical procedure kit, non-medicated, single-use
Device class
Class I
Regulation number
876.5450
GUDID distribution status
In Commercial Distribution

Other devices from Bucher Medical Enterprise LLC

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number

Other properties (10)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No