Catalog Number

506988

Brand Name

Robinson Nelaton Catheter

Version/Model Number

506988

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 18, 2019

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

-

Product Code

KOD

Product Code Name

Catheter, Urological

Public Device Record Key

6350bfca-878e-4253-9dc2-6cab6b2e21b5

Public Version Date

January 14, 2020

Public Version Number

3

DI Record Publish Date

February 10, 2017

Package DI Number

50768455145886

Quantity per Package

100

Contains DI Package

30768455145882

Package Discontinue Date

December 18, 2019

Package Status

Not in Commercial Distribution

Package Type

Case