Phantom® Fibula Nail System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: Phantom® Fibula Nail System FDA UDI
Generic Name: Orthopaedic guidewire, single-use FDA UDI
Device Name: 1.6mm x 400mm, Entry Guidewire, Ball Tip FDA UDI
Model / Reference: P36-912-1641 FDA UDI
Description: 1.6mm x 400mm, Entry Guidewire, Ball Tip FDA UDI

Identifiers

Catalog Number: P36-912-1641 FDA UDI
Primary DI / UDI-DI: 00889795146496 FDA UDI
FDA Product Code: HXI 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthopaedic guidewire, single-use

A high-quality, single-use orthopaedic guidewire designed to guide the insertion of cannulated/tubular orthopedic implants. Learn more about its features and regulatory compliance.

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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
HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC · 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: Paragon 28

Sources (1)

FDA UDI 0006ee09-b6a8-4c84-87de-94b496e33877 34 fields · synced Jun 27, 2026