Catalog Number

-

Brand Name

Vercise ™

Version/Model Number

DB-7105-N31

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

-

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

P150031,P150031,P150031

Product Code

MHY

Product Code Name

Stimulator, electrical, implanted, for parkinsonian tremor

Public Device Record Key

08e3bb66-94a5-41fb-9f2d-4dc7db2e892f

Public Version Date

November 24, 2021

Public Version Number

2

DI Record Publish Date

April 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-