NEWA Kit ND_PRD00200

GUDID 17290014660455

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

• Primary Device ID: 17290014660455
• NIH Device Record Key: 0b22ac59-994d-409f-9026-8af2e8100f9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEWA Kit
• Version Model Number: 1.5, Ivory demo
• Catalog Number: ND_PRD00200
• 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: 1-855-363-9633
• Email: service@endymed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290014660458 [Primary]
GS1	17290014660455 [Package]; Contains: 07290014660458; Package: Carton [10 Units]; Discontinued: 2018-09-30; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150005

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-03-21
• Device Publish Date: 2018-09-30

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