Duns Number:119193803
Device Description: By popular demand, our SmileGoods FlosSeas Flossers are now also available individually wr By popular demand, our SmileGoods FlosSeas Flossers are now also available individually wrapped as FlosSeas Singles! FlosSeas Flossers help you introduce flossing to younger patients. Specially designed for kids, FlosSeas feature high-quality nylon floss mounted securely to prevent breakage. 2-7/8" long. Assorted bright sea animal shapes. Includes two handy dispenser boxes containing 100 individually wrapped flossers each, 200 flossers total. Not intended for children under 3 years old.
Catalog Number
70-45281
Brand Name
SmileGoods FlosSeas Singles
Version/Model Number
70-45281
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
aaa06739-4cc4-47a4-b4df-97157956fea2
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896010532
Quantity per Package
12
Contains DI Package
00723896010525
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 |