Duns Number:119193803
Device Description: Compact and colorful, SmileGoods Cuties contain 12 yards of waxed, mint-flavored floss, re Compact and colorful, SmileGoods Cuties contain 12 yards of waxed, mint-flavored floss, ready for dispensing to patients. 72 per fishbowl canister in assorted bright colors.
Catalog Number
70-452110
Brand Name
SmileGoods Cuties Dental Floss Mint
Version/Model Number
FL-1729
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
587a7970-4bc2-4e44-8444-b85748b90f56
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896010518
Quantity per Package
4
Contains DI Package
00723896010501
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 |