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The Free Gliding SCFE Screw System
EUDAMEDFDA UDIClass I (EU MDR)
Ref SCF-MLD365Model SCF MALE DRIVER ASSEMBLY
Identity
- Trade Name
- The Free Gliding SCFE Screw System EUDAMEDFREE GLIDING SCFE SCREW SYSTEM FDA UDI
- Generic Name
- Orthopaedic implant driver FDA UDI
- Device Name
- SCF MALE DRIVER ASSEMBLY 6.5mm - STD FDA UDI
- Model / Reference
- SCF MALE DRIVER ASSEMBLY EUDAMEDSCF-MLD365 EUDAMEDFDA UDI
- Description
- SCF MALE DRIVER ASSEMBLY 6.5mm - STD FDA UDI
Identifiers
- Catalog Number
- SCF-MLD365 FDA UDI
- Primary DI / UDI-DI
- 07540194007940 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194SCF-MDARX EUDAMED
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic implant driver FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
The Free Gliding SCFE Screw System by Orthopediatrics Canada Ulc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7540194SCF-MDARX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OrthoPediatrics Canada ULC
- EUDAMED SRN
- CA-MF-000013010
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 82b818bc-8a48-48cf-9b62-28807a5b75d6 61 fields · synced Jun 20, 2026
- FDA UDI f4ea4030-374f-4463-85de-4f914a1e8fe9 36 fields · synced May 30, 2026