Catalog Number

009-400-0171

Brand Name

Matrix Wearable

Version/Model Number

009-400-0171

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

K202456

Product Code

DSH

Product Code Name

Recorder, Magnetic Tape, Medical

Public Device Record Key

76c83d45-aae9-41e5-9c8e-e8868628672b

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

March 11, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-