Duns Number:001315134
Device Description: Partial Carbon Fiber Body Fat scale
Catalog Number
-
Brand Name
Sunbeam
Version/Model Number
053891160506
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
cfda83a9-0d69-4609-a44c-e8e8174df818
Public Version Date
June 30, 2021
Public Version Number
1
DI Record Publish Date
June 22, 2021
Package DI Number
30053891160507
Quantity per Package
3
Contains DI Package
00053891160506
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 | 23 |
2 | A medical device with a moderate to high risk that requires special controls. | 164 |