Catalog Number

-

Brand Name

S-Cath™

Version/Model Number

5753

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

K132890,K132890

Product Code

KOB

Product Code Name

CATHETER, SUPRAPUBIC (AND ACCESSORIES)

Public Device Record Key

58fda13f-d3b3-482f-bd4f-6279f9b158f7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 17, 2015

Package DI Number

15055140702231

Quantity per Package

5

Contains DI Package

05055140702234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton