Catalog Number

GAR110

Brand Name

Conductive garment electrode glove sm

Version/Model Number

GAR110

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 21, 2021

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

-

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

K023212

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

0d4f4108-6dbc-4fe8-a72e-f9e493b782bc

Public Version Date

June 23, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-