Catalog Number

18-25

Brand Name

SIGNASPRAY

Version/Model Number

ELECTRODE SOLUTION AND SKIN PREP

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K780973,K780973,K780973

Product Code

GYB

Product Code Name

Media, Electroconductive

Public Device Record Key

5ff2bd59-9a37-423d-88ca-df0d51da8263

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

December 19, 2016

Package DI Number

20855683006269

Quantity per Package

4

Contains DI Package

10855683006262

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX