Duns Number:531958689
Device Description: The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatmen The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman who have Fitzpatrick skin types I-IV
Catalog Number
ND_PRD00426-00
Brand Name
NEWA Kit
Version/Model Number
1.5, pink
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
DEN150005,DEN150005
Product Code
PAY
Product Code Name
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Public Device Record Key
07d74d30-d2d8-4a60-ab0b-9e025acb355e
Public Version Date
March 21, 2019
Public Version Number
2
DI Record Publish Date
September 30, 2018
Package DI Number
17290014660837
Quantity per Package
10
Contains DI Package
07290014660830
Package Discontinue Date
September 30, 2018
Package Status
Not in Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |