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Gap Endo-Exo Medullary System Gap-LG050

by Orthopediatrics Canada ULC EUDAMEDGUDID

Active European Union

Ref GAP-LG050Model CORTICAL SCREW

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7540194GAP-SCWQE Basic UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07540194001108 UDI-DIDate20 Oct 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
The GAP Nail Endo-Exo Medullary System EUDAMED
Gap Endo-Exo Medullary System GUDID
Generic Name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
GAP-LG050, CORTICAL SCREW
Primary DI / UDI-DI
07540194001108
Basic UDI-DI
7540194GAP-SCWQE
FDA Product Code
HSB
EMDN Code
P09120402 Screws
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3020
Market of Registration
Sweden
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 50 Millimeter
Outer Diameter — 5.5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

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Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No