NEWA Kit ND_PRD00426-00

GUDID 17290014660837

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 h

ENDYMED MEDICAL LTD

Multi-modality skin contouring system Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit Home-use radio-frequency skin contouring unit
Primary Device ID17290014660837
NIH Device Record Key07d74d30-d2d8-4a60-ab0b-9e025acb355e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEWA Kit
Version Model Number1.5, pink
Catalog NumberND_PRD00426-00
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

Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290014660830 [Primary]
GS117290014660837 [Package]
Contains: 07290014660830
Package: carton [10 Units]
Discontinued: 2018-09-30
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-03-21
Device Publish Date2018-09-30

On-Brand Devices [NEWA Kit]

17290014660967The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of m
17290014660837The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of m
17290014660455The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of m
17290014660004The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of m
07290014660083The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of m

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