DEVICE: Tool Kit (06938695520029)

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Device Identifier (DI) Information

Tool Kit
FG2002
FG2002
Shanghai Kinetic Medical Co., Ltd.
06938695520029
GS1
1
KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KMC Medical Balloon Catheter Syringe Pump
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN 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.
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FDA Product Code

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Product Code Product Code Name
HRX Arthroscope
NDN Cement, Bone, Vertebroplasty
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 18 and 25 Degrees Celsius
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
May 26, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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+862150720558
qingmeiwei@kineticmedinc.com
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