Duns Number:008965063
Device Description: FLOSSUPS SUPER SLIP MINT 90S
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
158979
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
b26402c1-f231-46ba-8100-f47d45a1f3d1
Public Version Date
June 05, 2020
Public Version Number
1
DI Record Publish Date
May 28, 2020
Package DI Number
10311917144334
Quantity per Package
144
Contains DI Package
00311917144337
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 | 75 |
2 | A medical device with a moderate to high risk that requires special controls. | 74 |
U | Unclassified | 2 |