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Medichoice ORT04BX

by Owens & Minor Distribution, Inc.

Medichoice ORT04BX is a surgical towel (FDA Class II; FDA product code KKX, Drape, surgical) made by Owens & Minor Distribution, Inc., cleared under FDA 510(k) K001858 on 17 Aug 2000 and listed in FDA GUDID since 20 Aug 2016 (UDI-DI 10885632127526), 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

510(k) K001858

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885632127526 UDI-DI Date20 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK001858 Date17 Aug 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K001858 decided 17 Aug 2000 Active
  • FDA GUDID UDI-DI 10885632127526 listed 20 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K001858
  2. Listed FDA GUDID 10885632127526

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  • Withdrawn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
Surgical towel
Model / reference
ORT04BX
Primary DI / UDI-DI
10885632127526
510(k) Number
FDA product code
KKX
GMDN term
Surgical towel
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical towel

Cleared under the same submission (K001858)

and 8 more cleared under K001858

Similar devices

Other devices filed under FDA product code KKX (Drape, surgical).

Other devices from Owens & Minor Distribution, Inc.

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

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)