| Primary Device ID | 07540172019446 |
| NIH Device Record Key | 536dba01-a5ef-4190-be91-e14fb9959476 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EdgeDam™ Refill Heavy 5x5 Latex |
| Version Model Number | EDBLH5552 |
| Catalog Number | EDBLH5552 |
| Company DUNS | 626406016 |
| Company Name | CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |