Catalog Number

PRO3130

Brand Name

POWERPRO

Version/Model Number

PRO3130

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

-

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

K012320,K012320

Product Code

HAB

Product Code Name

SAW, POWERED, AND ACCESSORIES

Public Device Record Key

407b330d-4d50-4eaf-a9ef-4878d62e185f

Public Version Date

June 30, 2022

Public Version Number

2

DI Record Publish Date

April 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-