Duns Number:119193803
Device Description: SmileGoods FlosSeas Flossers help you introduce flossing to younger patients. Specially de SmileGoods FlosSeas Flossers help you introduce flossing to younger patients. Specially designed for children, FlosSeas feature high-quality nylon floss mounted securely to help prevent breakage. 2-7/8" long. 30 flossers per resealable bag in assorted bright sea animal shapes. Case includes 12 bags of 30 flossers, 360 total. Not individually wrapped. Not intended for children under 3 years of age.Also available in individually wrapped singles packs.
Catalog Number
70-45280
Brand Name
SmileGoods FlosSeas Flossers
Version/Model Number
70-45280
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
52462834-59fe-4093-b7c7-b9e6ba0aabeb
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896011188
Quantity per Package
10
Contains DI Package
00723896011171
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 |