Duns Number:006999528
Device Description: FLOSS NYLON WAX
Catalog Number
-
Brand Name
Kroger
Version/Model Number
USJ
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
cb36a0dd-98ec-42fd-a1cd-f7362979102d
Public Version Date
May 25, 2020
Public Version Number
1
DI Record Publish Date
May 15, 2020
Package DI Number
20011110799146
Quantity per Package
144
Contains DI Package
00011110799142
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 |