| Primary Device ID | B276V48000 |
| NIH Device Record Key | da3114ee-2fc6-4d5c-a242-01e5f76fa8a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Full Body Unit, 48 Lamp UVA Unit |
| Version Model Number | V4800 |
| Company DUNS | 070327895 |
| Company Name | ULTRALITE ENTERPRISES INC |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | 7709630594 |
| support@ultraliteuv.com | |
| Phone | 7709630594 |
| support@ultraliteuv.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B276V48000 [Primary] |
| FTC | Light, Ultraviolet, Dermatological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-12-21 |
| Device Publish Date | 2016-09-23 |
| B276HFDL28A0 - Hand and Foot Unit, 28 UVA Lamp Unit | 2018-12-21 |
| B276HFDL28NB0 - Hand and Foot Unit, 28 UVB Lamp Unit | 2018-12-21 |
| B276V44000 - Full Body Unit, 44 UVA Lamp Unit | 2018-12-21 |
| B276V4422ANB0 - Full Body Unit, 44 Lamp UVA/UVB Combination Unit | 2018-12-21 |
| B276V4444NB0 - Full Body Unit, 44 UVB lamps | 2018-12-21 |
| B276V48000 - Full Body Unit, 48 Lamp UVA Unit | 2018-12-21 |
| B276V48000 - Full Body Unit, 48 Lamp UVA Unit | 2018-12-21 |
| B276V4824ANB0 - Full Body Unit, 48 UVA/UVB Combination Unit | 2018-12-21 |
| B276V4848NB0 - Full Body Unit, 48 UVB Lamps | 2018-12-21 |