Duns Number:006999528
Device Description: PTB EASY FLEX TOTAL POWER II KDS CLSPFT W/SENS
Catalog Number
-
Brand Name
Kroger
Version/Model Number
ZQG
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
JEQ
Product Code Name
Toothbrush, Powered
Public Device Record Key
bbabf3a5-bffa-45c2-ade9-951c44795f39
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
May 15, 2020
Package DI Number
20041260382714
Quantity per Package
4
Contains DI Package
00041260379536
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |