Catalog Number

405229

Brand Name

Model 3150

Version/Model Number

405229

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 30, 2021

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

-

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

P950037

Product Code

OVJ

Product Code Name

Pulse generator, external pacemaker, dual-chamber

Public Device Record Key

027d62c7-1857-480f-91a1-c74f6b2460b4

Public Version Date

August 31, 2021

Public Version Number

4

DI Record Publish Date

October 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-