Catalog Number

4A5144

Brand Name

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

Version/Model Number

4A5144

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

1bd63c30-e2ac-4404-951c-5c18e6c4fa7d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 22, 2016

Package DI Number

10801741030557

Quantity per Package

50

Contains DI Package

00801741030550

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA