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Mark Line Offset Impactor Cup 254799

by Fournitures Hospitalieres Industrie

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 Number03661489547997 UDI-DIDate13 Mar 2019ListedStatusListed 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  • Withdrawn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
Mark Line Offset Impactor Cup
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Reference
254799
Primary DI / UDI-DI
03661489547997
510(k) Number
FDA Product Code
MEH
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class II
Regulation Number
888.3353
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K021108)

Show all (12)

Other devices from Fournitures Hospitalieres Industrie

See all devices from Fournitures Hospitalieres Industrie →

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

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