Catalog Number

GAR113

Brand Name

Conductive garment electrode glove XL

Version/Model Number

GAR113

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 13, 2020

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

45d53e40-eda0-4252-bea5-86e91da8b8c5

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-