Free Gliding Scfe Screw System

FDA UDI

Class I (US FDA UDI)

by Orthopediatrics Canada ULC

Identity

Trade Name: FREE GLIDING SCFE SCREW SYSTEM FDA UDI
Generic Name: Orthopaedic guidewire, single-use FDA UDI
Device Name: SCFE GUIDE WIRE Ø2.4mm x 330mm FDA UDI
Model / Reference: SCF-GWR324 FDA UDI
Description: SCFE GUIDE WIRE Ø2.4mm x 330mm FDA UDI

Identifiers

Catalog Number: SCF-GWR324 FDA UDI
Primary DI / UDI-DI: 07540194008145 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic guidewire, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 2.38 Millimeter FDA UDI
Length — 330 Millimeter FDA UDI

Category: Orthopaedic guidewire, single-use

Free Gliding Scfe Screw System by Orthopediatrics Canada ULC — Class I — FDA UDI — listed in FDA GUDID — 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 (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Orthopediatrics Canada ULC

Sources (1)

FDA UDI a8f8ebfc-2f8a-44ec-9e21-94eeb8c28ad3 37 fields · synced Jun 6, 2026