Osteotec CBG Guide L

FDA UDI

Class I (US FDA UDI)

by Osteotec, Ltd.

Identity

Trade Name: Osteotec CBG Guide L FDA UDI
Generic Name: Osteotomy guide, reusable FDA UDI
Device Name: To prevent the bones from moving while they are being cut, a jig has been included. K-wires are passed through the jig and are then drilled into each carpal bone. The tube saw can then be passed through the centre and the cut made. FDA UDI
Model / Reference: OST-CBG-25 FDA UDI
Description: To prevent the bones from moving while they are being cut, a jig has been included. K-wires are passed through the jig and are then drilled into each carpal bone. The tube saw can then be passed through the centre and the cut made. FDA UDI

Identifiers

Catalog Number: OST-CBG-25 FDA UDI
Primary DI / UDI-DI: 05060183095731 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Osteotomy guide, reusable 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

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Osteotomy guide, reusable

Osteotec CBG Guide L by Osteotec, Ltd. — 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: Osteotec, Ltd.

Sources (1)

FDA UDI 3bdfa606-35c4-49c4-bf74-5b9d12db7fc8 34 fields · synced May 31, 2026