DEVICE: Dilator (06938695524003)
Device Identifier (DI) Information
Dilator
FG2400
In Commercial Distribution
FG2400
Shanghai Kinetic Medical Co., Ltd.
FG2400
In Commercial Distribution
FG2400
Shanghai Kinetic Medical Co., Ltd.
KMC Kyphoplasty System consists of four components:
Balloon Catheter
Tool Kit (including Bone Filler Device, Dilator, Cannula, Drill and Guide Wire)
Puncture Needle
KMC Medical Balloon Catheter Syringe Pump
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
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? |
---|---|---|---|---|
60478 | Bone access cannula |
A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.
|
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 |
---|
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between 18 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
5108b834-72b6-4e4e-9c56-42a997c95a2b
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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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