Withings® - WITHINGS

Duns Number:260119720

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More Product Details

Catalog Number

-

Brand Name

Withings®

Version/Model Number

WBS09-white

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FRI

Product Code Name

Scale, Stand-On, Patient

Device Record Status

Public Device Record Key

510c7dc7-1ab7-4862-a010-6dfccfa16112

Public Version Date

May 27, 2021

Public Version Number

1

DI Record Publish Date

May 19, 2021

Additional Identifiers

Package DI Number

13700546707336

Quantity per Package

4

Contains DI Package

03700546707339

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master case

"WITHINGS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 5