Catalog Number

-

Brand Name

Bioness StimRouter Extended Hydrogel Electrode Set

Version/Model Number

ST2-7001

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

-

Product Code

GZF

Product Code Name

STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

Public Device Record Key

4d4a1c1a-2689-491a-8361-2f898cd7cb70

Public Version Date

September 20, 2021

Public Version Number

5

DI Record Publish Date

March 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-