Primary Device ID | E22190921 |
NIH Device Record Key | 670d3bd0-f695-41a1-adbe-cded29a0733a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Celalux III |
Version Model Number | 9092 |
Catalog Number | 9092 |
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 | false |
Expiration Date | true |
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 |
Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | E22190921 [Primary] |
EBZ | Activator, Ultraviolet, For Polymerization |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-08-31 |
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) |