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 with Fitzpatrick skin types I-IV.
Catalog Number
ND_PRD00446-00
Brand Name
NEWA Kit
Version/Model Number
1.5, Black
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
3bdf3fd8-9864-44fe-9c1c-0d09b2fae230
Public Version Date
October 01, 2021
Public Version Number
1
DI Record Publish Date
September 23, 2021
Package DI Number
17290014660080
Quantity per Package
10
Contains DI Package
07290014660083
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 |