Catalog Number

1044809

Brand Name

Actiwatch 2

Version/Model Number

Actiwatch 2 System

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

-

Product Code

GWQ

Product Code Name

Full-montage Standard Electroencephalograph

Public Device Record Key

a9e1ae27-c929-4a67-9a55-cc5a1b73e053

Public Version Date

January 26, 2021

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-