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DynaSafety Eye Cups, In Sealed Vials 3380

by Dynarex Corp.

DynaSafety Eye Cups, In Sealed Vials 3380 is an eye wash cup (FDA unclassified; FDA product code LXQ, Cup, Eye) made by Dynarex Corp., cleared under FDA 510(k) K151575 on 1 Sep 2015 and listed in FDA GUDID since 25 Apr 2022 (UDI-DI 00840117348967), 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) K151575

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 Number00840117348967 UDI-DI Date25 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151575 Date1 Sep 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151575 decided 1 Sep 2015 Active
  • FDA GUDID UDI-DI 00840117348967 listed 25 Apr 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151575
  2. Listed FDA GUDID 00840117348967

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DynaSafety Eye Cups, In Sealed Vials
Generic name
Eye wash cup
Model / reference
3380
Primary DI / UDI-DI
00840117348967
510(k) Number
FDA product code
LXQ
GMDN term
Eye wash cup
Device class
U
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LXQ (Cup, Eye).

Other devices from Dynarex Corp.

See all devices from Dynarex Corp. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)