| Primary Device ID | 00850043007005 |
| NIH Device Record Key | f09d1d48-802d-45c8-a33b-620e7b6dcda7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Del Sol Red Light Therapy System |
| Version Model Number | Cordless (US) |
| Catalog Number | 70393 |
| Company DUNS | 364134791 |
| Company Name | EDGE SYSTEMS LLC |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| 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 | false |
| Phone | 800-603-4996 |
| contact@edgeforlife.com | |
| Phone | 800-603-4996 |
| contact@edgeforlife.com | |
| Phone | 800-603-4996 |
| contact@edgeforlife.com | |
| Phone | 800-603-4996 |
| contact@edgeforlife.com | |
| Phone | 800-603-4996 |
| contact@edgeforlife.com | |
| Phone | 800-603-4996 |
| contact@edgeforlife.com | |
| Phone | 800-603-4996 |
| contact@edgeforlife.com | |
| Phone | 800-603-4996 |
| contact@edgeforlife.com | |
| Phone | 800-603-4996 |
| contact@edgeforlife.com | |
| Phone | 800-603-4996 |
| contact@edgeforlife.com | |
| Phone | 800-603-4996 |
| contact@edgeforlife.com | |
| Phone | 800-603-4996 |
| contact@edgeforlife.com | |
| Phone | 800-603-4996 |
| contact@edgeforlife.com | |
| Phone | 800-603-4996 |
| contact@edgeforlife.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850043007005 [Primary] |
| ILY | Lamp, Infrared, Therapeutic Heating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2017-08-16 |
| 00850043007340 | Del Sol Red Cordless LED Light for EU/CE only |
| 00850043007043 | Red LED Handpiece with Power Supply |
| 00850043007029 | Red LED Handpiece, 12V |
| 00850043007005 | Red Cordless LED - US |