Duns Number:119193803
Device Description: make flossing more fun! Specially designed for kids, Giraffe Flossers feature high-quality make flossing more fun! Specially designed for kids, Giraffe Flossers feature high-quality nylon floss mounted securely to prevent breakage. Individually wrapped. 200-box.Specifications:2 7/8" longAssorted bright giraffesNot intended for children under 3 years of age
Catalog Number
71-09861
Brand Name
SmileGoods Giraffe Flossers
Version/Model Number
7109861
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
5cade09e-0553-4125-83bc-f29cedc8d5e3
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 19, 2018
Package DI Number
00723896010884
Quantity per Package
8
Contains DI Package
00723896009222
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 |