Duns Number:606089605
Device Description: Magic Wand® Plus HV-265, personal hand-held electronic massage apparatus, variable speed.
Catalog Number
-
Brand Name
Magic Wand®
Version/Model Number
Plus HV-265
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
ISA
Product Code Name
Massager, Therapeutic, Electric
Public Device Record Key
7d6b6f7f-0bcf-4570-af3b-d99f922ad055
Public Version Date
September 09, 2020
Public Version Number
1
DI Record Publish Date
September 01, 2020
Package DI Number
10896909001982
Quantity per Package
20
Contains DI Package
00896909001985
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |