The Free Gliding SCFE Screw System
EUDAMEDFDA UDIClass I (EU MDR)
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
- SCFE CAP DRIVER FDA UDI
- Model / Reference
- CAP DRIVER EUDAMEDSCF-CDR200 EUDAMEDFDA UDI
- Description
- SCFE CAP DRIVER FDA UDI
Identifiers
- Catalog Number
- SCF-CDR200 FDA UDI
- Primary DI / UDI-DI
- 07540194007803 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194SCF-CDQW EUDAMED
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, 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
Single Use
No
Implantable
No
Reusable
Yes
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 2.5 Millimeter FDA UDI
Category: Surgical screwdriver, reusable
The Free Gliding SCFE Screw System by Orthopediatrics Canada Ulc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7540194SCF-CDQW | 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 72354ca9-8bd7-4a3d-ad7d-32584d7e1644 61 fields · synced Jun 18, 2026
- FDA UDI 5a78ca57-05c5-485f-b31b-3c5e90d94313 37 fields · synced May 30, 2026