Catalog Number

-

Brand Name

AUVON

Version/Model Number

EB10080B1

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

13abca75-85e3-467d-80d1-1e39297a1468

Public Version Date

September 17, 2021

Public Version Number

1

DI Record Publish Date

September 09, 2021

Package DI Number

16971292002243

Quantity per Package

150

Contains DI Package

06971292002246

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-