DEVICE: C2 CryoBalloon Focal Pear Catheter (00854924006330)

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Device Identifier (DI) Information

C2 CryoBalloon Focal Pear Catheter
FG-1033
FG-1033
C2 THERAPEUTICS, INC.
00854924006330
GS1
1
C2 CryoBalloon Focal Pear Catheter for C2 CryoBalloon Ablation System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
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
Gastrointestinal dilation balloon catheter A long, thin, flexible tube with an inflatable balloon at its distal tip typically used to endoscopically dilate gastrointestinal strictures, especially of the oesophagus, pylorus, and colon. The balloon is inflated to its prescribed diameter (typically between 6 mm and 20 mm) 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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FDA Product Code

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Product Code Product Code Name
GEH Unit, Cryosurgical, Accessories
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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
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius
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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
October 19, 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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No Customer Contact currently defined
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