Catalog Number

PCK00012

Brand Name

PowerGlide Pro

Version/Model Number

PCK00012

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

FOZ

Product Code Name

Catheter, intravascular, therapeutic, short-term less than 30 days

Public Device Record Key

c7e86577-1054-488a-b656-87b3e9fabc03

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

February 24, 2022

Package DI Number

10801741224567

Quantity per Package

6

Contains DI Package

00801741224560

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA