Duns Number:119193803
Device Description: Get the same high quality of leading brands at half the price with SmileGoods Easy Flex Fl Get the same high quality of leading brands at half the price with SmileGoods Easy Flex Floss Threaders. Large loop works with all floss types to make cleaning around bridges, braces, and implants easier than ever. 10 threaders per clear plastic case,
Catalog Number
71-09877P
Brand Name
Personalized SmileGoods Easy Flex Floss Threaders
Version/Model Number
7109877P
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
d90fede1-3e70-4819-9048-2ca6b73d0038
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 19, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |