Duns Number:060272465
Device Description: DENTEK CROSS FLOSSER 75CT FLS PICK 36
Catalog Number
-
Brand Name
DENTEK CROSS FLOSSER 75CT FLS PICK 36
Version/Model Number
20047701000711
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"
Yes
For Single-Use
Yes
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
JES
Product Code Name
Floss, Dental
Public Device Record Key
7fd49949-f0a7-4882-8794-486b3385923e
Public Version Date
October 31, 2022
Public Version Number
1
DI Record Publish Date
October 21, 2022
Package DI Number
20047701000711
Quantity per Package
75
Contains DI Package
00047701000717
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Multiple
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. | 6 |
U | Unclassified | 14 |