Catalog Number

HC1016

Brand Name

RediCath

Version/Model Number

HC1016

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

K142767,K142767,K142767

Product Code

GBM

Product Code Name

CATHETER, URETHRAL

Public Device Record Key

4cb11e24-31c5-44b5-9fb5-977eadd57650

Public Version Date

February 24, 2020

Public Version Number

2

DI Record Publish Date

August 27, 2018

Package DI Number

50851809002963

Quantity per Package

10

Contains DI Package

10851809002965

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case