Duns Number:006961700
Device Description: BR HDS SMSNC PRO ADV NP 3PK +1 HD
Catalog Number
-
Brand Name
Up&Up
Version/Model Number
2B5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 28, 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
Yes
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
9bc93db2-893f-4bd1-ac16-664c8ece5bbe
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
January 21, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 52 |
U | Unclassified | 12 |