Catalog Number

-

Brand Name

PS-843262

Version/Model Number

PS-843262

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"

-

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

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

8934e436-3ee3-4555-bfcd-049820cdc54d

Public Version Date

November 13, 2019

Public Version Number

1

DI Record Publish Date

November 05, 2019

Package DI Number

20850005864633

Quantity per Package

4

Contains DI Package

10850005864636

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-