Duns Number:690539978
Catalog Number
RD-953PRO WH
Brand Name
TANITA/InnerScan PRO Body Composition Monitor
Version/Model Number
RD-953PRO
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
PUH
Product Code Name
Analyzer, Body Composition, Exempt
Public Device Record Key
3f5ac2d6-9d14-4f40-a545-633c88b6999d
Public Version Date
September 04, 2020
Public Version Number
1
DI Record Publish Date
August 27, 2020
Package DI Number
14904785043685
Quantity per Package
5
Contains DI Package
04904785043688
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 47 |