| Primary Device ID | E22161971 |
| NIH Device Record Key | 9e8416d9-4ec0-4b2d-83e6-eeca508a6d9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CediTEC DB |
| Version Model Number | 6197 |
| Catalog Number | 6197 |
| Company DUNS | 316699578 |
| Company Name | VOCO GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | |
| 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 | |
| Phone | 999-999-9999 |
| xxx@xx.xx |
| 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 |
| 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 | E22161971 [Primary] |
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-28 |
| Device Publish Date | 2023-12-20 |
| E2216197 | Disc orange-pink 30 mm |
| E2216196 | Disc dark-pink 30 mm |
| E2216195 | Disc pink 30 mm |
| E22161971 | Disc orange-pink 30 mm |
| E22161961 | Disc dark-pink 30 mm |
| E22161951 | Disc pink 30 mm |