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Kitsune 2800-02-018

by Medshape, Inc.

Kitsune 2800-02-018 is a Class I device made by Medshape, Inc., listed in FDA GUDID since 19 May 2017 (UDI-DI M9702800020180), 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 NumberM9702800020180 UDI-DI Date19 May 2017ListedStatusListed 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  • Withdrawn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
Kitsune
Generic name
Surgical drill guide, reusable
Model / reference
2800-02-018
Primary DI / UDI-DI
M9702800020180
FDA product code
LXI
GMDN term
Surgical drill guide, reusable
Device class
Class I
Regulation number
878.4820
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)