Catalog Number

-

Brand Name

Epilog

Version/Model Number

E001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2022

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

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,K203827,K203827

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

7c013c3f-0576-4dd9-913b-8912815ddca7

Public Version Date

July 28, 2022

Public Version Number

2

DI Record Publish Date

January 01, 2022

Package DI Number

08600053881278

Quantity per Package

4

Contains DI Package

08600053881032

Package Discontinue Date

January 01, 2022

Package Status

Not in Commercial Distribution

Package Type

-