NEWA Kit ND_PRD00446-00

GUDID 07290014660083

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.

ENDYMED MEDICAL LTD

Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment 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 ID: 07290014660083
• NIH Device Record Key: 3bdf3fd8-9864-44fe-9c1c-0d09b2fae230
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEWA Kit
• Version Model Number: 1.5, Black
• Catalog Number: ND_PRD00446-00
• Company DUNS: 531958689
• Company Name: ENDYMED MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com
• Phone: 800-314-7508
• Email: support@myNEWA.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290014660083 [Primary]
GS1	17290014660080 [Package]; Package: carton [10 Units]; In Commercial Distribution

FDA Product Code

• PAY: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-01
• Device Publish Date: 2021-09-23

On-Brand Devices [NEWA Kit]

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