Catalog Number

-

Brand Name

S-Cath™

Version/Model Number

5759

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

93f3a13e-5fab-48e9-b97a-9b1ba926e9b6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 17, 2015

Package DI Number

15055140701203

Quantity per Package

5

Contains DI Package

05055140701206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton