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Corneal Trephine Depth Gauge 12-1010

by Sontec Instruments, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00192896072442 UDI-DI Date19 Sep 2018ListedStatusListed GUDID: not 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  • Withdrawn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
Corneal Trephine Depth Gauge
Generic Name
Ophthalmic knife, reusable
Model / Ref / Catalog
12-1010
Primary DI / UDI-DI
00192896072442
FDA Product Code
HRH
GMDN Term
Ophthalmic knife, reusable
Device Class
Class I
Regulation Number
886.4350
GUDID distribution status
Not in Commercial Distribution

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No