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MediChoice 58189

by Owens & Minor Distribution, Inc.

MediChoice 58189 is a Class I device made by Owens & Minor Distribution, Inc., cleared under FDA 510(k) K233578 on 22 Mar 2024 (1 earlier submission) and listed in FDA GUDID since 13 Mar 2025 (UDI-DI 10885632436277), active as of 23 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 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885632436277 UDI-DI Date13 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233578 Date22 Mar 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233578 decided 22 Mar 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10885632436277 listed 13 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131407
  2. Cleared FDA 510(k) K233578
  3. Listed FDA GUDID 10885632436277

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MediChoice
Generic name
Instrument tray, reusable
Model / reference
58189
Primary DI / UDI-DI
10885632436277
510(k) Number
FDA product code
FSM
GMDN term
Instrument tray, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K131407)

and 8 more cleared under K131407

Cleared under the same submission (K233578)

and 8 more cleared under K233578

Similar devices in this category

Other devices filed under Instrument tray, reusable.

Other devices from Owens & Minor Distribution, Inc.

See all devices from Owens & Minor Distribution, Inc. →

Properties

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