Gap Endo-Exo Medullary System
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- The GAP Nail Endo-Exo Medullary System EUDAMEDGAP ENDO-EXO MEDULLARY SYSTEM FDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDI
- Device Name
- GAP DEPTH GAGE WIRE Ø2.0mm x 360mm FDA UDI
- Model / Reference
- GAP-KDG360 EUDAMEDFDA UDILAG WIRE EUDAMED
- Description
- GAP DEPTH GAGE WIRE Ø2.0mm x 360mm FDA UDI
Identifiers
- Catalog Number
- GAP-KDG360 FDA UDI
- Primary DI / UDI-DI
- 07540194009975 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194GAP-DGWNF 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 Millimeter FDA UDILength — 360 Millimeter FDA UDI
Category: Orthopaedic guidewire, single-use
Gap Endo-Exo Medullary 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI 3e0fe13c-8d92-4d24-9849-65d4cd328012 37 fields · synced Jun 18, 2026
- EUDAMED 354d14f8-f318-425a-a87f-76e0a5701c93 61 fields · synced Jun 18, 2026