Catalog Number

394936

Brand Name

Etrinsa 8 SR-T

Version/Model Number

394936

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 24, 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

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

P950037

Product Code

NVZ

Product Code Name

Pulse generator, permanent, implantable

Public Device Record Key

d49b35da-ff1e-4fc2-902b-797b8b5e0316

Public Version Date

August 25, 2021

Public Version Number

5

DI Record Publish Date

December 09, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-