| Primary Device ID | E22190941 |
| NIH Device Record Key | 71bcbe5a-af13-4c3f-9793-6f90f08bd41c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Celalux III |
| Version Model Number | 9094 |
| Catalog Number | 9094 |
| Company DUNS | 316699578 |
| Company Name | VOCO GmbH |
| 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 | false |
| 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 | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E22190941 [Primary] |
| EBZ | Activator, Ultraviolet, For Polymerization |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-16 |
| Device Publish Date | 2024-05-08 |
| E22190931 | Rubber Shield, accessory to Celalux III |
| E22190921 | Device Base, accessory to Celalux III |
| E22190911 | Light guide 8 mm, autoclavable, accessory to Celalux III |
| E22190901 | High-Power LED curing-light |
| E22190941 | High-Power LED curing-light (pool) |