Catalog Number

FCS200ZT-6

Brand Name

Centurion

Version/Model Number

FCS200ZT-6

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

-

Product Code

EYJ

Product Code Name

HOLDER, URETERAL CATHETER

Public Device Record Key

e070570c-9b1f-4dd5-960f-54dad3f93ca8

Public Version Date

February 08, 2022

Public Version Number

1

DI Record Publish Date

January 31, 2022

Package DI Number

10653160270188

Quantity per Package

50

Contains DI Package

20653160270185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE