Catalog Number

-

Brand Name

NOISEFREE

Version/Model Number

DE-S017815

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

-

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

K142159

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

23c80886-e6a0-42b3-8583-58b1828dc9b7

Public Version Date

April 19, 2019

Public Version Number

1

DI Record Publish Date

April 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-