Small Bone Phantom Intramedullary Nail System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: Small Bone Phantom Intramedullary Nail System FDA UDI
Generic Name: Osteotomy guide, reusable FDA UDI
Device Name: Met-Cuneiform Guide, Left, 14°/22° FDA UDI
Model / Reference: P30-942-L114 FDA UDI
Description: Met-Cuneiform Guide, Left, 14°/22° FDA UDI

Identifiers

Catalog Number: P30-942-L114 FDA UDI
Primary DI / UDI-DI: 00889795049650 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Osteotomy guide, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

MRI Safety

MR Unsafe FDA UDI

Category: Osteotomy guide, reusable

Small Bone Phantom Intramedullary Nail System by Paragon 28 — 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: Paragon 28

Sources (1)

FDA UDI 187def4a-6be6-4637-8db6-fd022914cd87 34 fields · synced Jun 1, 2026