DEVICE: C2 CryoBalloon Full 8 Catheter (00854924006323)
Device Identifier (DI) Information
C2 CryoBalloon Full 8 Catheter
FG-1032
In Commercial Distribution
FG-1032
C2 THERAPEUTICS, INC.
FG-1032
In Commercial Distribution
FG-1032
C2 THERAPEUTICS, INC.
C2 CryoBalloon Full 8 Catheter for C2 CryoBalloon Ablation System
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
Yes | |
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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? |
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45712 | Gastrointestinal/biliary dilation balloon catheter |
A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GEH | Unit, Cryosurgical, Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K153541 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Storage Environment Humidity: between 10 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
534a5d05-43c2-4997-85a9-d0ea2135569d
July 06, 2018
3
October 19, 2016
July 06, 2018
3
October 19, 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
[?]
No Customer Contact currently defined