Catalog Number

-

Brand Name

VNS Therapy® Demipulse® Model 103 Generator

Version/Model Number

103

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"

Yes

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

P970003,P970003,P970003,P970003,P970003,P970003,P970003,P970003

Product Code

LYJ

Product Code Name

Stimulator, Autonomic Nerve, Implanted For Epilepsy

Public Device Record Key

8b518f49-3bc5-46f0-893c-38695fc6cecb

Public Version Date

March 05, 2020

Public Version Number

4

DI Record Publish Date

September 17, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-