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Mondeal 08-65360

by Mondeal Medical Systems GmbH

Listed FDA GUDID listing, not in commercial distribution

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 Number04050435066016 UDI-DI Date26 Jun 2017ListedStatusListed GUDID: not 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  • Withdrawn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
Mondeal
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / Ref / Catalog
08-65360
Description
MCD Screw 6.5 x 60 mm cannulated M4 partially threaded thread length 20 mm grey
Primary DI / UDI-DI
04050435066016
FDA Product Code
HWC
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Mondeal Medical Systems GmbH

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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