Catalog Number

-

Brand Name

REMI

Version/Model Number

R001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2022

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

K203827

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

fe7dd9bc-670a-428c-a0b2-cd18eccc821f

Public Version Date

July 28, 2022

Public Version Number

2

DI Record Publish Date

January 01, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-