Catalog Number

-

Brand Name

Bioness L300 Go Hydrogel Electrodes Set

Version/Model Number

LG3-5F00

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

GZI

Product Code Name

STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL

Public Device Record Key

c835a12a-ba40-4aa6-b557-d8dee3e2c8ea

Public Version Date

March 31, 2021

Public Version Number

4

DI Record Publish Date

August 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-