Pro-X1

FDA UDI

Class II (US FDA UDI)

by X-Bolt Orthopedics

Identity

Trade Name: Pro-X1 FDA UDI
Generic Name: Orthopaedic guidewire, single-use FDA UDI
Device Name: Ø2.5mm x 1000mm Long Guidewire (Ø3.9mm ball tip diam.) FDA UDI
Model / Reference: XBT024900 FDA UDI
Description: Ø2.5mm x 1000mm Long Guidewire (Ø3.9mm ball tip diam.) FDA UDI

Identifiers

Primary DI / UDI-DI: 05397283000717 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Orthopaedic guidewire, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 1000 Millimeter FDA UDI

Category: Orthopaedic guidewire, single-use

Pro-X1 by X-Bolt Orthopedics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic guidewire, single-use.

OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP. · Class II
Gen II Cannulated Screws — ORTHOPEDIATRICS CORP. · Class II
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 II	Pending data

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Manufacturer

Manufacturer: X-Bolt Orthopedics

Sources (1)

FDA UDI d2ff92f9-9b8f-43cd-9b7f-cf7e92176b3e 34 fields · synced May 30, 2026