Duns Number:119193803
Device Description: ur exclusive FlossBow Orthodontic Flosser is specially designed to help patients quickly a ur exclusive FlossBow Orthodontic Flosser is specially designed to help patients quickly and easily floss behind braces—without a threader.Floss faster and more often.Floss anywhere—on the go!Floss with one hand.With other orthodontic flossers, floss can pop loose from the thin extension. FlossBow features strong floss and secure end points to solve this problem. Plus, its double-ended design is like having two flossers in one! Ideal for both ortho and non-ortho users.
Catalog Number
71-09860
Brand Name
FlossBow Ortho Flossers
Version/Model Number
7109860
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
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
JES
Product Code Name
Floss, Dental
Public Device Record Key
06733907-02af-4777-84c7-504819a4516b
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 19, 2018
Package DI Number
00723896010877
Quantity per Package
10
Contains DI Package
00723896010860
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 |