Duns Number:352394143
Device Description: ISSA™ mini 2 Sensitive is a crazy soft, super-comfortable petite powered toothbrush. In a ISSA™ mini 2 Sensitive is a crazy soft, super-comfortable petite powered toothbrush. In addition to the brush head made 100% out of super-soft, ultra-hygienic silicone, the cleanest, softest toothbrush also has a smaller brush head fit for young brushers or adults who prefer a smaller brush surface and was created for those with sensitive gums. Brighten, whiten and polish without damaging the tooth enamel or irritating the gum tissue and enjoy your feather-soft brush head for up to a full year of smiles.
Catalog Number
-
Brand Name
ISSA™ mini 2 Sensitive
Version/Model Number
SUMMER SKY
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JEQ
Product Code Name
Toothbrush, Powered
Public Device Record Key
11dd6574-8fa7-4ffe-9e72-ae05779afe08
Public Version Date
June 03, 2022
Public Version Number
1
DI Record Publish Date
May 26, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |