Duns Number:006999528
Device Description: FLOSS EXTRA COMFORT MINT
Catalog Number
-
Brand Name
Kroger
Version/Model Number
UQW
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
db6a7240-0963-4e05-84d8-64f29f4c7af6
Public Version Date
May 25, 2020
Public Version Number
1
DI Record Publish Date
May 15, 2020
Package DI Number
10041260376839
Quantity per Package
72
Contains DI Package
00041260376832
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 | 13 |
2 | A medical device with a moderate to high risk that requires special controls. | 15 |