Catalog Number

-

Brand Name

C2 CryoBalloon EndoGrip

Version/Model Number

FG-1040

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"

-

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

K193036

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

d8638dfc-11f6-4475-b831-af09861fbe2e

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-