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72203004

by Smith & Nephew, Inc.

72203004 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K121904 on 11 Mar 2013 and listed in FDA GUDID since 29 Aug 2015 (UDI-DI 00885554018400), 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) K121904

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 Number00885554018400 UDI-DI Date29 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121904 Date11 Mar 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121904 decided 11 Mar 2013 Active
  • FDA GUDID UDI-DI 00885554018400 listed 29 Aug 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K121904
  2. Listed FDA GUDID 00885554018400

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Device sterilization/disinfection container, reusable
Model / Ref / Catalog
72203004
Primary DI / UDI-DI
00885554018400
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
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under Device sterilization/disinfection container, reusable.

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Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)