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399.585

by Synthes

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10886982202970 UDI-DI Date12 Oct 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  • Withdrawn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

Generic name
Orthopaedic chisel
Model / Ref / Catalog
399.585, 399585
Primary DI / UDI-DI
10886982202970
FDA product code
FZO
GMDN term
Orthopaedic chisel
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic chisel

Other devices from Synthes

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    Class II

  • Volt 68.134.111

    Class II

  • Volt 68.134.200

    Class II

  • 68.045.017

    Class II

  • 68.045.020

    Class II

  • 68.045.019

    Class II

See all devices from Synthes →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number

Other properties (11)

  • Supplied 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