Catalog Number

7131-60

Brand Name

Durata®

Version/Model Number

7131-60

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 13, 2018

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

Product Code

LWS

Product Code Name

Implantable cardioverter defibrillator (non-CRT)

Public Device Record Key

b05696f3-6628-4ff9-abb7-adf5fa366518

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

January 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-