Home GUDID 06938695502155 Bone Drill
Primary DI 06938695502155
Brand Bone Drill
Company Shanghai Kinetic Medical Co., Ltd.
Model FG2701
Published 2025-12-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name GAA Needle, Aspiration And Injection, Disposable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06938695502155 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06938695502155 06938695502155 6938695502155
GMDN Terms# Term, Definition table Term Definition Bone access channel kit A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 528198569 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration 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 06938695502254 Cannula FG2203 2025-12-09 06938695521026 Drill FG2100 2025-12-09 06938695527004 Bone Drill FG2700 2025-12-09 06938695522009 Cannula FG2200 FG2200 2016-12-05 06938695524003 Dilator FG2400 FG2400 2016-12-05 06938695530066 Puncture Needle FG3006 FG3006 2016-05-26 06938695537676 Dilator w/Cannula FG2410 FG2410 2020-05-31 06938695546067 KMC Guide Wire, 1.6mm, Blunt Tip KMC-000-00 2020-10-01 06938695546074 KMC Guide Wire, 1.6mm, Sharp Tip KMC-000-10 2020-10-01 06938695546081 KMC Access Needle, 11 Gauge, 95mm, Bevel Tip KMC-001-00 2020-10-01 06938695546098 KMC Access Needle, 11 Gauge, 95mm, Pyramid Tip KMC-001-10 2020-10-01 06938695546104 KMC Access Needle, 11 Gauge, 115mm, Pyramid Tip KMC-001-11 2020-10-01 06938695546111 KMC Access Needle, 11 Gauge, 115mm, Integrated Diamond Tip KMC-001-20 2020-10-01 06938695546128 KMC Access Needle, 11 Gauge, 115mm, Integrated Bevel Tip KMC-001-30 2020-10-01 06938695546135 KMC Access Needle, 13 Gauge, 95mm, Pyramid Tip KMC-002-00 2020-10-01 06938695546142 KMC Access Needle, 13 Gauge, 115mm, Pyramid Tip KMC-002-01 2020-10-01 06938695546159 KMC Access Needle, 13 Gauge, 115mm, Integrated Bevel Tip KMC-002-10 2020-10-01 06938695546166 KMC Balloon Catheter, 8 Gauge, 10mm KMC-003-10 2020-10-01 06938695546173 KMC Balloon Catheter, 8 Gauge, 15mm KMC-003-15 2020-10-01 06938695546180 KMC Balloon Catheter, 8 Gauge, 20mm KMC-003-20 2020-10-01
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