Catalog Number

-

Brand Name

Withings®

Version/Model Number

WBS04-White

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FRI

Product Code Name

Scale, Stand-On, Patient

Public Device Record Key

097dc3e7-acd2-49e5-8627-4100529cca97

Public Version Date

February 28, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

13700546701549

Quantity per Package

4

Contains DI Package

03700546701542

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master case