Catalog Number

GAR888

Brand Name

Bio Knit Conductive cuff

Version/Model Number

GAR888

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

-

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

K103719

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

1deaad8b-b62d-4d54-bf36-35e22fcb70e2

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

March 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-