Free Gliding Scfe Screw System
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- The Free Gliding SCFE Screw System EUDAMEDFREE GLIDING SCFE SCREW SYSTEM FDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDI
- Device Name
- SCFE GUIDE WIRE Ø2.4mm - PACKAGE OF 2 FDA UDI
- Model / Reference
- SCF-GWR324-PKG2 EUDAMEDFDA UDIGUIDE WIRE EUDAMED
- Description
- SCFE GUIDE WIRE Ø2.4mm - PACKAGE OF 2 FDA UDI
Identifiers
- Catalog Number
- SCF-GWR324-PKG2 FDA UDI
- Primary DI / UDI-DI
- 07540194008152 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194SCFE-GWTS EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- Z12139085 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Orthopaedic guidewire, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
Yes
Implantable
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
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
- Outer Diameter — 2.38 Millimeter FDA UDILength — 330 Millimeter FDA UDI
Category: Orthopaedic guidewire, single-use
Free Gliding Scfe Screw System by Orthopediatrics Canada ULC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, single-use.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP. · Class II
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP. · Class II
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- 2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc · Class I
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- Ball Tip Wire — Orthopedic Designs North America, Inc. · Class I
- Flower Orthopedics — FLOWER ORTHOPEDICS CORPORATION · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI f1180d2c-4ebc-4a8a-8953-6e229316bb32 37 fields · synced Jun 19, 2026
- EUDAMED 0b284816-3f04-497c-901a-87569b40ce9d 61 fields · synced Jun 19, 2026