Catalog Number

RLA-82-3

Brand Name

RUSCH

Version/Model Number

IPN053692

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

K010420,K010420

Product Code

KOD

Product Code Name

CATHETER, UROLOGICAL

Public Device Record Key

778b846c-85d7-473c-98c1-dcca533b0715

Public Version Date

December 04, 2020

Public Version Number

9

DI Record Publish Date

September 16, 2016

Package DI Number

24026704551044

Quantity per Package

100

Contains DI Package

04026704551040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box