VirtuGuide

FDA UDI

Class I (US FDA UDI)

by Crossroads Extremity Systems Llc

Identity

Trade Name: VirtuGuide FDA UDI
Generic Name: Bone awl, reusable FDA UDI
Device Name: VirtuGuide instruments are used with MotoBAND CP Implant System. The MotoBAND® CP Implant System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. When used for these indications, the MotoBAND® CP Implant System with the exception of the 2-hole plate may be used with the MotoCLIP®/HiMAX® Implant System. FDA UDI
Model / Reference: 7000-JRW4 FDA UDI
Description: VirtuGuide instruments are used with MotoBAND CP Implant System. The MotoBAND® CP Implant System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. When used for these indications, the MotoBAND® CP Implant System with the exception of the 2-hole plate may be used with the MotoCLIP®/HiMAX® Implant System. FDA UDI

Identifiers

Catalog Number: 7000-JRW4 FDA UDI
Primary DI / UDI-DI: 00810112596267 FDA UDI
FDA Product Code: LXH FDA UDI
FZX FDA UDI
GMDN Term: Bone awl, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
878.4800 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

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: Bone awl, reusable

VirtuGuide by Crossroads Extremity Systems Llc — 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: Crossroads Extremity Systems Llc

Sources (1)

FDA UDI 4af9a2b9-90d5-49b3-a8d5-ad08fa485fdf 34 fields · synced May 31, 2026