Duns Number:119193803
Device Description: make flossing as simple as brushing. Patients floss more effectively and more frequently. make flossing as simple as brushing. Patients floss more effectively and more frequently. Slotted lock-buttons hold floss securely. 50 flossers per bag with instruction included in each bag.
Catalog Number
70-39740
Brand Name
Floss-Hands Floss Aids
Version/Model Number
KWC-23
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
JES
Product Code Name
Floss, Dental
Public Device Record Key
2356dc05-6363-4cb6-a29d-2de0312ca1a3
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896009925
Quantity per Package
40
Contains DI Package
00723896009918
Package Discontinue Date
-
Package Status
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 | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |