DEVICE: Puncture Needle (06938695510839)
Device Identifier (DI) Information
Puncture Needle
FG3008
In Commercial Distribution
FG3008
Shanghai Kinetic Medical Co., Ltd.
FG3008
In Commercial Distribution
FG3008
Shanghai Kinetic Medical Co., Ltd.
KMC Kyphoplasty System consists of four components:
Balloon Catheter
Tool Kit
Puncture Needle
KMC Medical Balloon Catheter Syringe Pump
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58031 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRX | Arthroscope |
NDN | Cement, Bone, Vertebroplasty |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K113742 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: less than 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between 18 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 3 Millimeter |
Device Record Status
66f2a319-c77b-4866-a314-9ec3399f3c74
July 06, 2018
3
December 05, 2016
July 06, 2018
3
December 05, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+862150720558
qingmeiwei@kineticmedinc.com
qingmeiwei@kineticmedinc.com