Duns Number:119193803
Device Description: Each pocket-sized dispenser contains 12 yards of PTFE floss. See-through plastic dispense Each pocket-sized dispenser contains 12 yards of PTFE floss. See-through plastic dispensers are color-coded by style and flavor. 1 5/8" tall. 72 dispensers per case.
Catalog Number
70-45206
Brand Name
SmileGoods Premium (PTFE) Dental Floss Mint
Version/Model Number
FL-641
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
e09957e7-9430-4c19-9c5f-3779ba4326be
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896010303
Quantity per Package
16
Contains DI Package
00723896010297
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 |