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ExactEtch 2325K

by Diamatrix

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813059011343 UDI-DI Date24 Oct 2019ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
ExactEtch
Generic name
Ophthalmic knife, single-use
Model / reference
2325K
Primary DI / UDI-DI
00813059011343
FDA product code
HNN
GMDN term
Ophthalmic knife, single-use
Device class
Class I
Regulation number
886.4350
GUDID distribution status
In Commercial Distribution

Other devices from Diamatrix

See all devices from Diamatrix →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Manufacturing date: No