Catalog Number

7122Q-52

Brand Name

Durata™

Version/Model Number

7122Q-52

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P950022,P950022,P950022

Product Code

NVY

Product Code Name

Permanent defibrillator electrodes

Public Device Record Key

a45a210f-4ec6-45fe-a73e-3839469d336f

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

April 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-