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Sharps Crate 4631

by Dynarex Corp.

Sharps Crate 4631 is a Class II device made by Dynarex Corp., cleared under FDA 510(k) K082042 on 3 Sep 2008 and listed in FDA GUDID since 16 Jun 2017 (UDI-DI 00616784463117), 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) K082042

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 Number00616784463117 UDI-DI Date16 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082042 Date3 Sep 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082042 decided 3 Sep 2008 Active
  • FDA GUDID UDI-DI 00616784463117 listed 16 Jun 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082042
  2. Listed FDA GUDID 00616784463117

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sharps Crate
Generic name
Sharps container
Model / reference
4631
Primary DI / UDI-DI
00616784463117
FDA product code
MMK
GMDN term
Sharps container
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sharps container

Cleared under the same submission (K082042)

and 8 more cleared under K082042

Similar devices

Other devices filed under FDA product code MMK (Container, Sharps).

Other devices from Dynarex Corp.

See all devices from Dynarex Corp. →

Properties

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