| Primary Device ID | 17290014660127 |
| NIH Device Record Key | a16f6de8-e2eb-4170-a3b2-4e172c807f7a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEWA+, Kit, US, PINK |
| Version Model Number | Plus, PINK |
| Catalog Number | ND_PRD00457-00 |
| 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 |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com | |
| Phone | 800-314-7508 |
| support@myNEWA.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290014660120 [Primary] |
| GS1 | 17290014660127 [Package] Contains: 07290014660120 Package: Carton [6 Units] In Commercial Distribution |
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-28 |
| Device Publish Date | 2023-11-20 |
| 17290014660127 - NEWA+, Kit, US, PINK | 2023-11-28The 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. |
| 17290014660127 - NEWA+, Kit, US, PINK | 2023-11-28 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin |
| 17290016814351 - EndyGel | 2023-07-12 EndyGel is an Electroconductive gel media used with external electrode to reduce the impedance (resistance to alternating curren |
| 07290016814361 - PURE Laser, System | 2023-06-27 The PURE Laser system is a non-invasive laser based system used for Hair Removal |
| 07290016814378 - PURE Laser, EPL810 HP | 2023-06-27 The handpiece of the PURE Laser system which delivers pulsed laser light (wavelength 810nm) from the diode array to the treatme |
| 17290014660110 - NEWA PLUS Kit | 2022-01-17 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin |
| 07290014660083 - NEWA Kit | 2021-10-01 The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles |
| 17290014660028 - NEWA PLUS Kit | 2021-05-06 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin |
| 07290014660014 - NEWA PLUS Kit | 2021-04-28 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin |