Catalog Number

-

Brand Name

Neon8 KIT

Version/Model Number

TF04K

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"

-

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

K151576,K151576,K151576

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

0c5bcd12-935b-421a-9048-92ef3928eb11

Public Version Date

April 01, 2022

Public Version Number

1

DI Record Publish Date

March 24, 2022

Package DI Number

05391530950121

Quantity per Package

5

Contains DI Package

05391530950107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box