NEWA PLUS Kit ND_PRD00450-00

GUDID 17290014660110

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.

ENDYMED MEDICAL LTD

Radio-frequency skin surface treatment system
Primary Device ID17290014660110
NIH Device Record Key77d38495-d2e4-48d6-b46c-ae7c6a1c6320
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEWA PLUS Kit
Version Model NumberPlus, Gold
Catalog NumberND_PRD00450-00
Company DUNS531958689
Company NameENDYMED MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com
Phone800-314-7508
Emailsupport@myNEWA.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290014660113 [Primary]
GS117290014660110 [Package]
Contains: 07290014660113
Package: Carton [6 Units]
In Commercial Distribution

FDA Product Code

PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-17
Device Publish Date2022-01-09

On-Brand Devices [NEWA PLUS Kit]

07290014660014The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment
17290014660028The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment
17290014660110The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.