Bone Biopsy Device BC1111

GUDID 06938695537874

Bone Biopsy Device, Square, 9G (3.5mm)

Shanghai Kinetic Medical Co., Ltd.

Bone grafting cannula
Primary Device ID06938695537874
NIH Device Record Keya2dec142-cbb7-453c-92ae-0d81aa4b8f97
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Biopsy Device
Version Model NumberBC1111
Catalog NumberBC1111
Company DUNS528198569
Company NameShanghai Kinetic Medical Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com
Phone+862150720558
Emailqingmeiwei@kineticmedinc.com

Device Dimensions

Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106938695537874 [Primary]

FDA Product Code

MJGDevice, Percutaneous, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-31

On-Brand Devices [Bone Biopsy Device]

06938695537874Bone Biopsy Device, Square, 9G (3.5mm)
06938695537690Bone Biopsy Device, 9G (3.5mm)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.