Duns Number:688550503
Device Description: AROMA VITAMIN C SHOWER HEAD
Catalog Number
-
Brand Name
Aroma Sense
Version/Model Number
AS-701ST
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IQE
Product Code Name
Orthosis, Lumbar
Public Device Record Key
11b76abb-dd14-4c7e-9a9b-3b575782ba3b
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
January 14, 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 | 6 |