Catalog Number

FG-1032

Brand Name

C2 CryoBalloon Full 8 Catheter

Version/Model Number

FG-1032

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153541

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

534a5d05-43c2-4997-85a9-d0ea2135569d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-