Catalog Number

-

Brand Name

Azure™ S DR MRI SureScan™

Version/Model Number

W3DR01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

P980035,P980035

Product Code

LWP

Product Code Name

Implantable pulse generator, pacemaker (non-CRT)

Public Device Record Key

144db912-b6da-491c-b521-e211c74dc799

Public Version Date

February 07, 2022

Public Version Number

3

DI Record Publish Date

January 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-