Primary Device ID | E2211109 |
NIH Device Record Key | 3157540a-a26f-41a7-8dbb-6e8c6130bbef |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Provicol QM |
Version Model Number | 1109 |
Catalog Number | 1109 |
Company DUNS | 316699578 |
Company Name | VOCO GmbH |
Device Count | 3 |
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 | 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 |
Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | E2211109 [Unit of Use] |
HIBCC | E22111091 [Primary] |
EMA | Cement, Dental |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-09-07 |
Device Publish Date | 2020-08-28 |
E22110741 | Eugenol-free temporary luting cement with calcium hydroxide. |
E22110991 | Eugenol-free temporary luting cement with calcium hydroxide. |
E2211109 | Eugenol-free temporary luting cement with calcium hydroxide. |