| Primary Device ID | J00644050 |
| NIH Device Record Key | 5490ae69-e1f1-4a1e-ad3f-81855f229d4b |
| Commercial Distribution Discontinuation | 2021-05-25 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | COLTENE ADHESIVE |
| Version Model Number | 4405 |
| Catalog Number | 4405 |
| Company DUNS | 480017482 |
| Company Name | Coltène/Whaledent AG |
| 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 |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |