Catalog Number

FCS-1073

Brand Name

Clik-FIX

Version/Model Number

FCS-1073

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EYJ

Product Code Name

Holder, Ureteral Catheter

Public Device Record Key

6c62a4b8-f441-414e-bf95-79a53d3b0ed4

Public Version Date

July 02, 2018

Public Version Number

1

DI Record Publish Date

May 30, 2018

Package DI Number

10850933007211

Quantity per Package

50

Contains DI Package

00850933007214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-