Duns Number:079343581
Catalog Number
-
Brand Name
ADULT MINT FLOSSER PIKS
Version/Model Number
6070540128
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
b7655489-ad9f-4e4b-bb38-7aef07a5a1dc
Public Version Date
September 14, 2022
Public Version Number
1
DI Record Publish Date
September 06, 2022
Package DI Number
D89260705401282
Quantity per Package
120
Contains DI Package
D89260705401281
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bundle
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 208 |
2 | A medical device with a moderate to high risk that requires special controls. | 61 |