Duns Number:008965063
Device Description: Digital glass scale with body analysis features.
Catalog Number
-
Brand Name
Well at Walgreens
Version/Model Number
FG9301
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)
Yes
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
8988f8dd-bc44-4b9c-a934-c210cdd95c59
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 16, 2016
Package DI Number
10311917159925
Quantity per Package
4
Contains DI Package
00311917159928
Package Discontinue Date
October 19, 2016
Package Status
Not in Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 75 |
2 | A medical device with a moderate to high risk that requires special controls. | 74 |
U | Unclassified | 2 |