AccessGUDID - DEVICE: C2 CryoBalloon Cartridge, Regular (00854924006101)

GUDID

Device Identifier (DI) Information

Brand Name: C2 CryoBalloon Cartridge, Regular
Version or Model: FG-1010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG-1010
Company Name: C2 THERAPEUTICS, INC.

Primary DI Number: 00854924006101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929139249 *Terms of Use

Device Description: C2 CryoBalloon Cartridge, Regular, for C2 CryoBalloon Ablation System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14239	High-pressure medical gas hose	A length of flexible tube intended to deliver and withstand gases under very high pressure, e.g., 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEH	Unit, Cryosurgical, Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1d301c96-bcbd-44fd-8846-42dbc2880f12
Public Version Date: July 04, 2022
Public Version Number: 3
DI Record Publish Date: October 19, 2016