Catalog Number

-

Brand Name

NA

Version/Model Number

6996SQ41

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 23, 2016

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

P920015

Product Code

DTB

Product Code Name

permanent pacemaker Electrode

Public Device Record Key

cadba1a9-9904-4790-9669-57fae60863f8

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-