Catalog Number

CPA00045A

Brand Name

PowerLoc MAX

Version/Model Number

CPA00045A

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

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

99c3306b-92a1-4503-bfc5-e16e480cb85c

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

November 13, 2018

Package DI Number

10801741182997

Quantity per Package

5

Contains DI Package

00801741182990

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA