Catalog Number

-

Brand Name

NA

Version/Model Number

DB-4254

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

-

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

549668fe-c0cc-4ada-8caf-335559e698bc

Public Version Date

October 29, 2021

Public Version Number

4

DI Record Publish Date

December 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-