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Kerrison Rongeur 7397-75

by Koros USA, Inc.

Kerrison Rongeur 7397-75 is a Class I device made by Koros USA, Inc., listed in FDA GUDID since 1 Dec 2021 (UDI-DI 10840199523280), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10840199523280 UDI-DI Date1 Dec 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Kerrison Rongeur
Generic name
Craniofacial rongeur, reusable
Model / Ref / Catalog
7397-75
Primary DI / UDI-DI
10840199523280
FDA product code
HTX
GMDN term
Craniofacial rongeur, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal rongeurOrthopaedic joint/limb rongeurCraniofacial rongeur, reusableRib rongeur

Other devices from Koros USA, Inc.

See all devices from Koros USA, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (10, all answered No)