NEWA+, Kit, US, PINK ND_PRD00457-00

GUDID 17290014660127

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

Home-use radio-frequency skin contouring unit
Primary Device ID17290014660127
NIH Device Record Keya16f6de8-e2eb-4170-a3b2-4e172c807f7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEWA+, Kit, US, PINK
Version Model NumberPlus, PINK
Catalog NumberND_PRD00457-00
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290014660120 [Primary]
GS117290014660127 [Package]
Contains: 07290014660120
Package: Carton [6 Units]
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-28
Device Publish Date2023-11-20

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