Duns Number:036981694
Catalog Number
SC-548
Brand Name
Homedics
Version/Model Number
SC-548
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
cd1f9c34-b64c-4e42-9bc5-3fc99da78ea5
Public Version Date
June 04, 2018
Public Version Number
1
DI Record Publish Date
May 02, 2018
Package DI Number
10077784031152
Quantity per Package
4
Contains DI Package
00077784031155
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 30 |