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Bahadir USA Y100.54

by Bahadir USA LLC

Bahadir USA Y100.54 is a Class II device made by Bahadir USA LLC, cleared under FDA 510(k) K131407 on 12 Aug 2014 and listed in FDA GUDID since 31 Jul 2017 (UDI-DI 00858307007044), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K131407

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858307007044 UDI-DI Date31 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK131407 Date12 Aug 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131407 decided 12 Aug 2014 Active
  • FDA GUDID UDI-DI 00858307007044 listed 31 Jul 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131407
  2. Listed FDA GUDID 00858307007044

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bahadir USA
Generic name
Device sterilization/disinfection container, reusable
Model / reference
Y100.54
Description
LID PERFORATED - BLUE 600X400MM
Primary DI / UDI-DI
00858307007044
510(k) Number
FDA product code
KCT
GMDN term
Device sterilization/disinfection container, reusable
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution

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Properties

  • Lot / batch number
Other properties (14, all answered No)