Home GUDID 05060183095700 Osteotec CBG Spike S
Primary DI 05060183095700
Brand Osteotec CBG Spike S
Company OSTEOTEC LIMITED
Model OST-CBG-16
Catalog number OST-CBG-16
Device description A spike has been included in the kit, this is to be inserted through the body of the tube saw and is used to centralize the saw when starting the cut.
Published 2022-02-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05060183095700 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05060183095700 05060183095700 5060183095700
GMDN Terms# Term, Definition table Term Definition Bone awl A spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 348489386 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05060183095793 Osteotec SFI Instruments OSTF-Ins OSTF-Ins 2025-11-26 05060183095809 Osteotec SFI Sizer OSTF-Sizer OSTF-Sizer 2025-11-26 05060183090002 Osteotec Silicone Finger Implant - Size 00 OSTF-00 OSTF-00 2022-02-04 05060183090019 Osteotec Silicone Finger Implant - Size 0 OSTF-0 OSTF-0 2022-02-04 05060183090026 Osteotec Silicone Finger Implant - Size 1 OSTF-1 OSTF-1 2022-02-04 05060183090033 Osteotec Silicone Finger Implant - Size 2 OSTF-2 OSTF-2 2022-02-04 05060183090040 Osteotec Silicone Finger Implant - Size 3 OSTF-3 OSTF-3 2022-02-04 05060183090057 Osteotec Silicone Finger Implant - Size 4 OSTF-4 OSTF-4 2022-02-04 05060183090064 Osteotec Silicone Finger Implant - Size 5 OSTF-5 OSTF-5 2022-02-04 05060183090071 Osteotec Silicone Finger Implant - Size 6 OSTF-6 OSTF-6 2022-02-04 05060183090088 Osteotec Silicone Finger Implant - Size 7 OSTF-7 OSTF-7 2022-02-04 05060183090095 Osteotec Silicone Finger Implant - Size 8 OSTF-8 OSTF-8 2022-02-04 05060183090101 Osteotec Silicone Finger Implant - Size 9 OSTF-9 OSTF-9 2022-02-04 05060183095595 Osteotec CBG Tube Saw S - size 1 OST-CBG-01 OST-CBG-01 2022-02-04 05060183095601 Osteotec CBG Tube Saw S - size 2 OST-CBG-02 OST-CBG-02 2022-02-04 05060183095618 Osteotec CBG Tube Saw S - size 3 OST-CBG-03 OST-CBG-03 2022-02-04 05060183095625 Osteotec CBG Tube Saw S - size 4 OST-CBG-04 OST-CBG-04 2022-02-04 05060183095632 Osteotec CBG Tube Saw L - size 5 OST-CBG-05 OST-CBG-05 2022-02-04 05060183095649 Osteotec CBG Tube Saw L - size 6 OST-CBG-06 OST-CBG-06 2022-02-04 05060183095656 Osteotec CBG Tube Saw L - size 7 OST-CBG-07 OST-CBG-07 2022-02-04
Other Devices Sharing Product Codes#