← Back to catalogue

The Free Gliding SCFE Screw System

EUDAMEDFDA UDI

Class I (EU MDR)

Ref SCF-SRL100Model SLIDE RULERRef SCF-GWR324-CoCrModel GUIDE WIRERef SCF-GWR320-PKG2Ref SCF-GWR324-PKG6Ref SCF-GWR328Ref SCF-GWR328-CoCr-PKG2Ref SCF-GWR324-CoCr-PKG6Ref SCF-GWR328-PKG6Ref SCF-GWR320-CoCrRef SCF-GWR328-CoCrRef SCF-GWR328-CoCr-PKG6Ref SCF-GWR320-CoCr-PKG2Ref SCF-CAR050Model REAMERRef SCF-GWR324-CoCr-PKG2

by OrthoPediatrics Canada ULC

Identity

Trade Name
The Free Gliding SCFE Screw System EUDAMED
FREE GLIDING SCFE SCREW SYSTEM FDA UDI
Generic Name
Orthopaedic guidewire, single-use FDA UDI
Cannulated surgical drill bit, reusable FDA UDI
Medical ruler, reusable FDA UDI
Device Name
SCFE GUIDE WIRE Ø2.80mm - PACKAGE OF 6 FDA UDI
SCFE GUIDE WIRE CoCr Ø2.4mm - PACKAGE OF 2 FDA UDI
SCFE GUIDE WIRE CoCr Ø2.4mm - PACKAGE OF 6 FDA UDI
SCFE GUIDE WIRE CoCr Ø2.4mm x 330mm FDA UDI
SCFE GUIDE WIRE Ø2.4mm - PACKAGE OF 6 FDA UDI
SCFE GUIDE WIRE Ø2.80mm x 330mm FDA UDI
SCFE GUIDE WIRE CoCr Ø2.80mm - PACKAGE OF 2 FDA UDI
SCFE GUIDE WIRE CoCr Ø2.80mm x 330mm FDA UDI
SCFE REAMER Ø5.0mm FDA UDI
SCFE GUIDE WIRE CoCr Ø2.0mm - PACKAGE OF 2 FDA UDI
SCFE GUIDE WIRE CoCr Ø2.0mm x 330mm FDA UDI
SCFE GUIDE WIRE Ø2.0mm - PACKAGE OF 2 FDA UDI
SCFE SLIDE RULER FDA UDI
SCFE GUIDE WIRE CoCr Ø2.80mm - PACKAGE OF 6 FDA UDI
Model / Reference
SLIDE RULER EUDAMED
SCF-SRL100 EUDAMEDFDA UDI
SCF-GWR328-PKG6 EUDAMEDFDA UDI
SCF-GWR324-CoCr-PKG2 EUDAMEDFDA UDI
SCF-GWR324-CoCr-PKG6 EUDAMEDFDA UDI
SCF-GWR324-CoCr EUDAMEDFDA UDI
SCF-GWR324-PKG6 EUDAMEDFDA UDI
SCF-GWR328 EUDAMEDFDA UDI
SCF-GWR328-CoCr-PKG2 EUDAMEDFDA UDI
SCF-GWR328-CoCr EUDAMEDFDA UDI
SCF-CAR050 EUDAMEDFDA UDI
SCF-GWR320-CoCr-PKG2 EUDAMEDFDA UDI
SCF-GWR320-CoCr EUDAMEDFDA UDI
SCF-GWR320-PKG2 EUDAMEDFDA UDI
SCF-GWR328-CoCr-PKG6 EUDAMEDFDA UDI
GUIDE WIRE EUDAMED
REAMER EUDAMED
Description
SCFE GUIDE WIRE Ø2.80mm - PACKAGE OF 6 FDA UDI
SCFE GUIDE WIRE CoCr Ø2.4mm - PACKAGE OF 2 FDA UDI
SCFE GUIDE WIRE CoCr Ø2.4mm - PACKAGE OF 6 FDA UDI
SCFE GUIDE WIRE CoCr Ø2.4mm x 330mm FDA UDI
SCFE GUIDE WIRE Ø2.4mm - PACKAGE OF 6 FDA UDI
SCFE GUIDE WIRE Ø2.80mm x 330mm FDA UDI
SCFE GUIDE WIRE CoCr Ø2.80mm - PACKAGE OF 2 FDA UDI
SCFE GUIDE WIRE CoCr Ø2.80mm x 330mm FDA UDI
SCFE REAMER Ø5.0mm FDA UDI
SCFE GUIDE WIRE CoCr Ø2.0mm - PACKAGE OF 2 FDA UDI
SCFE GUIDE WIRE CoCr Ø2.0mm x 330mm FDA UDI
SCFE GUIDE WIRE Ø2.0mm - PACKAGE OF 2 FDA UDI
SCFE SLIDE RULER FDA UDI
SCFE GUIDE WIRE CoCr Ø2.80mm - PACKAGE OF 6 FDA UDI

Identifiers

Catalog Number
SCF-GWR328-PKG6 FDA UDI
SCF-GWR324-CoCr-PKG2 FDA UDI
SCF-GWR324-CoCr-PKG6 FDA UDI
SCF-GWR324-CoCr FDA UDI
SCF-GWR324-PKG6 FDA UDI
SCF-GWR328 FDA UDI
SCF-GWR328-CoCr-PKG2 FDA UDI
SCF-GWR328-CoCr FDA UDI
SCF-CAR050 FDA UDI
SCF-GWR320-CoCr-PKG2 FDA UDI
SCF-GWR320-CoCr FDA UDI
SCF-GWR320-PKG2 FDA UDI
SCF-SRL100 FDA UDI
SCF-GWR328-CoCr-PKG6 FDA UDI
Primary DI / UDI-DI
07540194008015 EUDAMEDFDA UDI
07540194008190 EUDAMEDFDA UDI
07540194008244 EUDAMEDFDA UDI
07540194008251 EUDAMEDFDA UDI
07540194008237 EUDAMEDFDA UDI
07540194008169 EUDAMEDFDA UDI
07540194008176 EUDAMEDFDA UDI
07540194008275 EUDAMEDFDA UDI
07540194008268 EUDAMEDFDA UDI
07540194007773 EUDAMEDFDA UDI
07540194008213 EUDAMEDFDA UDI
07540194008206 EUDAMEDFDA UDI
07540194008121 EUDAMEDFDA UDI
07540194008282 EUDAMEDFDA UDI
Basic UDI-DI
7540194SCF-HSHFT7J EUDAMED
7540194SCFE-GWTS EUDAMED
7540194SCFE-DRT7 EUDAMED
FDA Product Code
LXH FDA UDI
HTO FDA UDI
HTJ FDA UDI
EMDN Code
L0923 ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE EUDAMED
Z12139085 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
L1508 REAMERS, REUSABLE EUDAMED
GMDN Term
Orthopaedic guidewire, single-use FDA UDI
Cannulated surgical drill bit, reusable FDA UDI
Medical ruler, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Class IIa EUDAMED
Regulation Number
888.4540 FDA UDI
888.4300 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMEDEUDAMED

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 2.8 Millimeter FDA UDI
Length — 330 Millimeter FDA UDI
Outer Diameter — 2.38 Millimeter FDA UDI
Lumen/Inner Diameter — 3 Millimeter FDA UDI
Outer Diameter — 5 Millimeter FDA UDI
Outer Diameter — 2 Millimeter 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
OrthoPediatrics Canada ULC
EUDAMED SRN
CA-MF-000013010
Authorised Representative
MedEnvoy Global BV NL-AR-000024028

Sources (28)

  • EUDAMED ac13af1e-e7fe-440a-acf4-4730adea6391 61 fields · synced Aug 1, 2026
  • FDA UDI 5b66508e-d7b3-4d83-9f53-b6b57bf9e6d2 37 fields · synced May 29, 2026
  • FDA UDI 2f78fea5-2449-4831-a1dc-4ba10118830d 37 fields · synced May 30, 2026
  • FDA UDI d2920dd8-7960-477f-a2b0-f4c2e7286dd7 37 fields · synced May 30, 2026
  • FDA UDI f1f860b9-f061-4e49-a6d8-0767f7f6731b 37 fields · synced May 30, 2026
  • FDA UDI cf4052a3-ce06-452f-8bc9-0be509bbc705 37 fields · synced May 30, 2026
  • FDA UDI fc9ffc3f-8f5f-4931-b008-9f2ac85d3a32 37 fields · synced May 30, 2026
  • FDA UDI 815c40f6-f69c-42c4-a1b7-145a62bd9bab 37 fields · synced May 30, 2026
  • FDA UDI de722f4e-e438-47ac-82a4-280ad663561a 37 fields · synced May 30, 2026
  • FDA UDI 0b9651d8-c933-4516-b01e-c7dc54fac20b 37 fields · synced May 30, 2026
  • FDA UDI c0a987c5-f32c-4946-9802-9961a000177d 37 fields · synced May 30, 2026
  • FDA UDI 19a79ffb-c8e4-40a4-b40f-a1cdd186ffae 37 fields · synced May 30, 2026
  • FDA UDI 16943a69-079b-4caa-b40a-43c4e5928c4c 37 fields · synced May 30, 2026
  • FDA UDI 638b816b-3850-472d-a283-48428564a9c8 36 fields · synced May 30, 2026
  • FDA UDI 345efad3-65c2-4a0c-a4ae-8a5e8b41d3e3 37 fields · synced May 30, 2026
  • EUDAMED f478013d-586a-4e01-933a-f08ac951e4b7 61 fields · synced Jul 9, 2026
  • EUDAMED 8de969a8-5987-4315-ae35-c1f0513e46eb 61 fields · synced Jul 10, 2026
  • EUDAMED 82658fc0-735f-4e06-89ec-c84250fe081e 61 fields · synced Jul 13, 2026
  • EUDAMED bb6215d2-2dc9-4a38-b702-ff012f953b77 61 fields · synced Jul 19, 2026
  • EUDAMED 487ce157-9fcc-499d-aa24-ecd2820be560 61 fields · synced Jul 19, 2026
  • EUDAMED 5dd0e717-8d99-43bb-9e82-fb3e8d8152dd 61 fields · synced Jul 22, 2026
  • EUDAMED d4c04d49-201d-42fe-8827-d2b26fbb5363 61 fields · synced Jul 22, 2026
  • EUDAMED 2e26ed4f-2d72-4457-bcb5-e1bfd94af804 61 fields · synced Jul 25, 2026
  • EUDAMED dbf8dd74-09a4-4aab-a3bf-dfb00d4f4599 61 fields · synced Jul 26, 2026
  • EUDAMED 50e9144d-7d34-4c73-baff-afcfeea7d592 61 fields · synced Jul 27, 2026
  • EUDAMED 19d7ba99-09f4-468a-9114-bda1cd44e5df 61 fields · synced Jul 28, 2026
  • EUDAMED 0b641b38-e153-44d8-bb9f-1eabba7e8615 61 fields · synced Jul 29, 2026
  • EUDAMED 1cea49ee-4c27-4074-9432-4a3bc3d86edf 61 fields · synced Aug 1, 2026