Catalog Number

-

Brand Name

HiDow

Version/Model Number

HD-09E

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K210383

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

5ba19f54-15c8-49a2-b6ca-4c0b5fd6216c

Public Version Date

May 24, 2022

Public Version Number

2

DI Record Publish Date

April 22, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-