Bone Filler Device FG2510

GUDID 06938695537683

Bone Filler Device, Flat Tip, 9G (3.5mm)

Shanghai Kinetic Medical Co., Ltd.

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Primary Device ID06938695537683
NIH Device Record Key6e9359b2-f2f1-47c2-a630-4e38fa8883f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Filler Device
Version Model NumberFG2510
Catalog NumberFG2510
Company DUNS528198569
Company NameShanghai Kinetic Medical Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn
Phone+862150720558
Emailqingmeiwei@shkmc.com.cn

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS106938695537683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

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 Filler Device]

06938695525017KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit (including Bone Fi
06938695525000KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit (including Bone Fi
06938695537713Bone Filler Device, Bevel Tip, 9G (3.5mm)
06938695537706Bone Filler Device, Lateral Open Tip, 9G (3.5mm)
06938695537683Bone Filler Device, Flat Tip, 9G (3.5mm)
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