| Primary Device ID | J003E0123140018001 |
| NIH Device Record Key | 3f7ce569-638a-435a-a0f9-a8bfe0282f9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TC cavity Burs Round |
| Version Model Number | E012314001800 |
| Catalog Number | E012314001800 |
| 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 | true |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *N/A |
| Special Storage Condition, Specify | Between 0 and 0 *N/A |
| Special Storage Condition, Specify | Between 0 and 0 *N/A |
| Special Storage Condition, Specify | Between 0 and 0 *N/A |
| Special Storage Condition, Specify | Between 0 and 0 *N/A |
| Special Storage Condition, Specify | Between 0 and 0 *N/A |
| Special Storage Condition, Specify | Between 0 and 0 *N/A |
| Special Storage Condition, Specify | Between 0 and 0 *N/A |
| Special Storage Condition, Specify | Between 0 and 0 *N/A |
| Special Storage Condition, Specify | Between 0 and 0 *N/A |
| Special Storage Condition, Specify | Between 0 and 0 *N/A |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J003E0123140018001 [Primary] |
| EJL | BUR, DENTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[J003E0123140018001]
Moist Heat or Steam Sterilization
[J003E0123140018001]
Moist Heat or Steam Sterilization
[J003E0123140018001]
Moist Heat or Steam Sterilization
[J003E0123140018001]
Moist Heat or Steam Sterilization
[J003E0123140018001]
Moist Heat or Steam Sterilization
[J003E0123140018001]
Moist Heat or Steam Sterilization
[J003E0123140018001]
Moist Heat or Steam Sterilization
[J003E0123140018001]
Moist Heat or Steam Sterilization
[J003E0123140018001]
Moist Heat or Steam Sterilization
[J003E0123140018001]
Moist Heat or Steam Sterilization
[J003E0123140018001]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2022-11-20 |