Osteotec CBG Guide L

Basic Information

• Brand Name: Osteotec CBG Guide L
• Primary DI: 05060183095731
• Version / Model: OST-CBG-25
• Catalog Number: OST-CBG-25
• Company Name: OSTEOTEC LIMITED
• Labeler DUNS: 348489386
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-04
• Public Version: 1
• Public Version Date: 2022-02-14
• Public Version Status: New
• Public Device Record Key: 3bdfa606-35c4-49c4-bf74-5b9d12db7fc8

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61917	Osteotomy guide, reusable	A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060183095731	GS1