Gap Endo-Exo Medullary System

FDA UDI

Class I (US FDA UDI)

by Orthopediatrics Canada ULC

Identity

Trade Name: GAP ENDO-EXO MEDULLARY SYSTEM FDA UDI
Generic Name: Orthopaedic guidewire, single-use FDA UDI
Device Name: GAP GUIDE WIRE Ø1.6mm x 457mm FDA UDI
Model / Reference: GAP-KWG016 FDA UDI
Description: GAP GUIDE WIRE Ø1.6mm x 457mm FDA UDI

Identifiers

Catalog Number: GAP-KWG016 FDA UDI
Primary DI / UDI-DI: 07540194010025 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: Length — 457.2 Millimeter FDA UDI
Outer Diameter — 1.6 Millimeter FDA UDI

Category: Orthopaedic guidewire, single-use

Gap Endo-Exo Medullary 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.

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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 02bd40c2-9f53-4bc8-bf22-9a8320c74049 37 fields · synced May 30, 2026