| Primary Device ID | J003E0123341016001 |
| NIH Device Record Key | 18441947-f033-4239-ac71-cfda1dacb00a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TC cavity Burs Round |
| Version Model Number | E012334101600 |
| Catalog Number | E012334101600 |
| Company DUNS | 480538495 |
| Company Name | MAILLEFER INSTRUMENTS HOLDING Sàrl |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |