Catalog Number

1999-40

Brand Name

Optisense™

Version/Model Number

1999-40

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

P960013,P960013

Product Code

NVN

Product Code Name

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Public Device Record Key

8d3c0083-bdd0-452e-9651-bea2476f87df

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

February 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-