Duns Number:529903321
Catalog Number
-
Brand Name
Smart Body Fat Scale
Version/Model Number
EF-655B4
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
49c3e022-5eee-4f1f-bff0-47dec7a0dbb9
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 21, 2019
Package DI Number
16947468554571
Quantity per Package
1
Contains DI Package
06947468554574
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
1pcs/box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |