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Intra-Op Toric Axis Marker II W/5 Degree Ae-2794N

by Katena Products, Inc.

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 Number00841668131220 UDI-DI Date7 Dec 2022ListedStatusListed 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  • Withdrawn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
Intra-Op Toric Axis Marker II W/5 Degree
Generic Name
Corneal marker, reusable
Model / Ref / Catalog
AE-2794N
Primary DI / UDI-DI
00841668131220
FDA Product Code
HMR
GMDN Term
Corneal marker, reusable
Device Class
Class I
Regulation Number
886.4570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Corneal marker, reusable

Other devices from Katena Products, Inc.

See all devices from Katena Products, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt

Other properties (12)

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