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Malleolar screws (half threaded) 4.5/65 mm 001-0009-065

by mahe medical gmbh

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 NumberEMAH00100090650 UDI-DI Date25 Jul 2016ListedStatusListed 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  • Withdrawn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
Malleolar screws (half threaded) 4.5/65 mm
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / Ref / Catalog
001-0009-065
Primary DI / UDI-DI
EMAH00100090650
FDA Product Code
HWC
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 4.5 Millimeter
Length — 65.0 Millimeter

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile

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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