Osteotec CBG Tube Saw S - size 1

FDA UDI

Class I (US FDA UDI)

by Osteotec, Ltd.

Identity

Trade Name: Osteotec CBG Tube Saw S - size 1 FDA UDI
Generic Name: Bone trephine, reusable FDA UDI
Device Name: The 8 tube saws, ranging from 6.5mm Outside Diameter to 17mm Outside Diameter, are sized so that the inside diameter of the larger saw will cut a dowel that will compression fit into the hole formed by the outer diameter of the next size down. The saws and the accompanying instrumentation will allow accurate removal of damaged arthritic bone and insertion of a healthy bone dowel to encourage fusion. FDA UDI
Model / Reference: OST-CBG-01 FDA UDI
Description: The 8 tube saws, ranging from 6.5mm Outside Diameter to 17mm Outside Diameter, are sized so that the inside diameter of the larger saw will cut a dowel that will compression fit into the hole formed by the outer diameter of the next size down. The saws and the accompanying instrumentation will allow accurate removal of damaged arthritic bone and insertion of a healthy bone dowel to encourage fusion. FDA UDI

Identifiers

Catalog Number: OST-CBG-01 FDA UDI
Primary DI / UDI-DI: 05060183095595 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Bone trephine, 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: Bone trephine, reusable

Osteotec CBG Tube Saw S - size 1 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 1c893426-cde6-46a7-b09e-7807fe0a0ddb 34 fields · synced Jun 6, 2026