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STERIMED, Inc. 1010260I3636VA

by Sterimed, Inc.

STERIMED, Inc. 1010260I3636VA is a Class II device made by Sterimed, Inc., cleared under FDA 510(k) K931202 on 16 Dec 1993 and listed in FDA GUDID since 20 Oct 2021 (UDI-DI 00815588025884), 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) K931202

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 Number00815588025884 UDI-DI Date20 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK931202 Date16 Dec 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K931202 decided 16 Dec 1993 Active
  • FDA GUDID UDI-DI 00815588025884 listed 20 Oct 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K931202
  2. Listed FDA GUDID 00815588025884

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
STERIMED, Inc.
Generic name
Sterilization packaging, single-use
Model / Ref / Catalog
1010260I3636VA
Primary DI / UDI-DI
00815588025884
510(k) Number
FDA product code
FRG
GMDN term
Sterilization packaging, single-use
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sterilization packaging, single-use

Cleared under the same submission (K931202)

and 8 more cleared under K931202

Other devices from Sterimed, Inc.

See all devices from Sterimed, Inc. →

Properties

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