Catalog Number

-

Brand Name

PowerPumpTM dp System Patient cassette

Version/Model Number

941013

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

Yes

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

K093409,K093409

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

8d56c16e-afca-4b17-9c45-c55ccd0c4599

Public Version Date

May 27, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

17350021987027

Quantity per Package

10

Contains DI Package

17350021986136

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-