Duns Number:189583599
Device Description: Body Composition Scale
Catalog Number
-
Brand Name
Balance
Version/Model Number
0391
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)
-
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
1bdaf554-1c14-4508-8210-d6ed182e0079
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
10875011003916
Quantity per Package
4
Contains DI Package
00875011003919
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 30 |