Gap Endo-Exo Medullary System

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Canada ULC

Identity

Trade Name: GAP ENDO-EXO MEDULLARY SYSTEM FDA UDI
Generic Name: Bone nail end-cap FDA UDI
Device Name: Nail Cap 1.5mm High FDA UDI
Model / Reference: GAP-CP015 FDA UDI
Description: Nail Cap 1.5mm High FDA UDI

Identifiers

Catalog Number: GAP-CP015 FDA UDI
Primary DI / UDI-DI: 07540194002181 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Bone nail end-cap FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

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: Height — 1.5 Millimeter FDA UDI

Category: Bone nail end-cap

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

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Also classified as Bone nail end-cap.

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PNP Femur — ORTHOPEDIATRICS CORP. · Class II
PNP Femur — ORTHOPEDIATRICS CORP. · Class II
EXPert Nail — Synthes · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Orthopediatrics Canada ULC

Sources (1)

FDA UDI 46636816-b72c-46b3-ba7b-614ea0a8ad66 37 fields · synced May 30, 2026