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: Fluted surgical drill bit, reusable FDA UDI
Device Name: GAP LAG ENDMILL FDA UDI
Model / Reference: GAP-DLF155 FDA UDI
Description: GAP LAG ENDMILL FDA UDI

Identifiers

Catalog Number: GAP-DLF155 FDA UDI
Primary DI / UDI-DI: 07540194009876 FDA UDI
FDA Product Code: LYS FDA UDI
GMDN Term: Fluted surgical drill bit, reusable 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

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 — 212 Millimeter FDA UDI
Outer Diameter — 7.975 Millimeter FDA UDI

Category: Fluted surgical drill bit, reusable

Gap Endo-Exo Medullary System by Orthopediatrics Canada ULC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 6c010dae-6cf9-47f4-8b70-8614a885ea1d 37 fields · synced Jun 1, 2026