Catalog Number

-

Brand Name

N/A

Version/Model Number

3320L

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

H020007

Product Code

MRU

Product Code Name

implanted subcortical electrical Stimulator (motor disorders)

Public Device Record Key

52e32507-14b4-4763-8cf4-0226aa828a1d

Public Version Date

December 08, 2020

Public Version Number

1

DI Record Publish Date

November 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-