Duns Number:531958689
Device Description: The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive tre The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman with Fitzpatrick skin types I-IV.
Catalog Number
ND_PRD00439-00
Brand Name
NEWA PLUS Kit
Version/Model Number
Plus, Blue
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
PAY
Product Code Name
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Public Device Record Key
46fb4d59-f34b-425b-ad0e-42d816f44164
Public Version Date
May 06, 2021
Public Version Number
1
DI Record Publish Date
April 28, 2021
Package DI Number
17290014660028
Quantity per Package
6
Contains DI Package
07290014660021
Package Discontinue Date
-
Package Status
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 |