Duns Number:119193803
Device Description: shred-resistant nylon floss and smooth cores that fit inside dispensers more securely.200 shred-resistant nylon floss and smooth cores that fit inside dispensers more securely.200 yards
Catalog Number
70-452101
Brand Name
SmileGoods Floss Dispenser Refill Waxed Mint
Version/Model Number
840D/80T MINT WAXED
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
7e46489e-b78f-42c3-a056-e2de9537aeb3
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896010402
Quantity per Package
4
Contains DI Package
00723896010396
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 |