Catalog Number

3202-1

Brand Name

ULTRASOFT™

Version/Model Number

3202-1

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

-

Product Code

KGZ

Product Code Name

Accessories, Catheter

Public Device Record Key

5267fbc4-4a22-4119-a2a9-65e6abf9c030

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 15, 2016

Package DI Number

10650551068508

Quantity per Package

12

Contains DI Package

00650551068501

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX