Catalog Number

PRO3600

Brand Name

POWERPRO

Version/Model Number

PRO3600

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2022

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

-

Product Code

HAB

Product Code Name

SAW, POWERED, AND ACCESSORIES

Public Device Record Key

1b688349-27bf-4853-a871-34be6ad9ee5c

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

April 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-