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Customed 712057462216

by Customed, Inc.

Customed 712057462216 (9002216) is a Class II device made by Customed, Inc., cleared under FDA 510(k) K081633 on 11 Aug 2008 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI M20890022161), 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) K081633

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 NumberM20890022161 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK081633 Date11 Aug 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081633 decided 11 Aug 2008 Active
  • FDA GUDID UDI-DI M20890022161 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K081633
  2. Listed FDA GUDID M20890022161

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Customed
Generic name
Surgical/medical face mask, single-use
Model / Ref / Catalog
712057462216, 9002216
Primary DI / UDI-DI
M20890022161
510(k) Number
FDA product code
FXX
GMDN term
Surgical/medical face mask, single-use
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical/medical face mask, single-use

Cleared under the same submission (K081633)

and 3 more cleared under K081633

Similar devices

Other devices filed under FDA product code FXX (Mask, Surgical).

Other devices from Customed, Inc.

See all devices from Customed, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)