Catalog Number

4A7116

Brand Name

Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Coude Urethral Catheter Kit

Version/Model Number

4A7116

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FCM

Product Code Name

Tray, catheterization, sterile urethral, with or without catheter (kit)

Public Device Record Key

82f9ce34-6895-46e8-8d23-85ff9c764465

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 06, 2016

Package DI Number

10801741046466

Quantity per Package

50

Contains DI Package

00801741046469

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA