Catalog Number

4894278NR-02

Brand Name

Stimuplex®

Version/Model Number

4894278NR-02

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"

Yes

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

-

Product Code

BXN

Product Code Name

STIMULATOR, NERVE, BATTERY-POWERED

Public Device Record Key

c3325e9a-9b30-44c4-9078-c4f7e1632ea1

Public Version Date

March 05, 2019

Public Version Number

1

DI Record Publish Date

February 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-