Duns Number:036981694
Catalog Number
ESBS-58
Brand Name
EatSmart
Version/Model Number
ESBS-58
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
a0ad6ba8-19d8-4a8f-bbe0-4af20667f472
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 02, 2017
Package DI Number
10077784028138
Quantity per Package
2
Contains DI Package
00077784028131
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 |