Duns Number:078497467
Device Description: Glass Body Analysis Scale
Catalog Number
-
Brand Name
Beurer
Version/Model Number
BG17
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 30, 2020
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
PUH
Product Code Name
Analyzer, Body Composition, Exempt
Public Device Record Key
27aa65e1-8626-469a-8c53-ffbab4f4cd65
Public Version Date
March 31, 2020
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
10736211162219
Quantity per Package
5
Contains DI Package
00736211162212
Package Discontinue Date
March 30, 2020
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |
| U | Unclassified | 2 |