Catalog Number

3014

Brand Name

SJM™

Version/Model Number

3014

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

P140009

Product Code

MHY

Product Code Name

STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Public Device Record Key

aab5ab26-2fb0-44e2-9c66-fc18a5f34d0c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-