DEVICE: C2 CryoBalloon Cartridge, Regular (00854924006101)

Device Identifier (DI) Information

C2 CryoBalloon Cartridge, Regular
FG-1010
In Commercial Distribution
FG-1010
C2 THERAPEUTICS, INC.
00854924006101
GS1

1
929139249 *Terms of Use
C2 CryoBalloon Cartridge, Regular, for C2 CryoBalloon Ablation System
CLOSE

Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
High-pressure medical gas tubing A flexible, cylindrical device that is used to deliver and withstand gases under very high pressure, i.e., greater than 200 bar/3000 pounds per square inch (psi). It may be composed of any of several malleable or semi-rigid materials, e.g., plastic, rubber or nylon, and braided with cotton wool and/or stainless steel. It is typically used to transport high pressure compressed medical gas to a pressure regulating device. It is available in various lengths, including standard coil lengths. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GEH Unit, Cryosurgical, Accessories
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 106 Degrees Kelvin
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

1d301c96-bcbd-44fd-8846-42dbc2880f12
March 29, 2018
2
October 19, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE