Catalog Number

-

Brand Name

Brookstone

Version/Model Number

BS150

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

-

Product Code

MNW

Product Code Name

Analyzer, Body Composition

Public Device Record Key

76669b45-6539-4895-ae57-b260589f2a7b

Public Version Date

May 06, 2020

Public Version Number

1

DI Record Publish Date

April 28, 2020

Package DI Number

10077784035402

Quantity per Package

2

Contains DI Package

00077784035405

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugate