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Mcintyre Fish Hook Needle Holder Ae-6400

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 Number00841668138083 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  • Withdrawn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
Mcintyre Fish Hook Needle Holder
Generic Name
Suturing needle holder, reusable
Model / Ref / Catalog
AE-6400
Primary DI / UDI-DI
00841668138083
FDA Product Code
FHQ
GMDN Term
Suturing needle holder, reusable
Device Class
Class I
Regulation Number
876.4730
GUDID distribution status
In Commercial Distribution

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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