Catalog Number

PRO2038RFB

Brand Name

POWER PRO

Version/Model Number

PRO2038RFB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 07, 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

6f96fa01-8266-4d4f-a1c3-5d27c31079c8

Public Version Date

June 08, 2022

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-