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Insulin Syringe 6944

by Dynarex Corp.

Insulin Syringe 6944 is a Class II device made by Dynarex Corp., cleared under FDA 510(k) K112057 on 14 Dec 2011 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00616784694429), 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) K112057

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 Number00616784694429 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112057 Date14 Dec 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112057 decided 14 Dec 2011 Active
  • FDA GUDID UDI-DI 00616784694429 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112057
  2. Listed FDA GUDID 00616784694429

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Insulin Syringe
Generic name
Insulin syringe/needle, basic
Model / reference
6944
Primary DI / UDI-DI
00616784694429
510(k) Number
FDA product code
FMF
GMDN term
Insulin syringe/needle, basic
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FMF (Syringe, Piston).

Other devices from Dynarex Corp.

See all devices from Dynarex Corp. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)