Duns Number:119193803
Device Description: Mint-flavored Floss Picks combine an interdental pick with multi-strand floss in one conve Mint-flavored Floss Picks combine an interdental pick with multi-strand floss in one convenient, disposable patient favorite. Tension-mounted floss resists breakage. Bendable pick helps clean hard-to-reach areas. 200 individually wrapped picks per box.
Catalog Number
70-45284
Brand Name
Floss Picks
Version/Model Number
FH-009 White Mint
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
c6d45964-12cc-41b0-9ce8-51a02e06df0b
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896010556
Quantity per Package
10
Contains DI Package
00723896010549
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 |