Catalog Number

-

Brand Name

N/A

Version/Model Number

3708695

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"

-

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

P960009,P960009,H050003,H050003,H020007,H020007

Product Code

MBX

Product Code Name

STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED

Public Device Record Key

87855deb-6bfb-4159-9e02-85cd136775c9

Public Version Date

August 02, 2019

Public Version Number

1

DI Record Publish Date

July 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-