Catalog Number

EC129

Brand Name

RUSCH

Version/Model Number

IPN054337

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

K000070,K000070,K000070,K000070

Product Code

KOD

Product Code Name

CATHETER, UROLOGICAL

Public Device Record Key

ac247fbf-741a-456b-b452-1d62f63fd5c7

Public Version Date

January 18, 2021

Public Version Number

6

DI Record Publish Date

August 13, 2019

Package DI Number

24026704662917

Quantity per Package

50

Contains DI Package

14026704662910

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box