Catalog Number

102409

Brand Name

Remote Control (Onyx)

Version/Model Number

102409

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

DSB

Product Code Name

Plethysmograph, Impedance

Public Device Record Key

678ecfdf-3a03-4d51-8f69-2c6e68496245

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Package DI Number

37630039300761

Quantity per Package

1

Contains DI Package

17630039300767

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-