Catalog Number

-

Brand Name

AUVON

Version/Model Number

EB1544020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

6158a35a-0726-443c-8849-e334690f0b4f

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

February 24, 2020

Package DI Number

16971292002113

Quantity per Package

50

Contains DI Package

06971292002116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box