| Primary Device ID | D6919053037 |
| NIH Device Record Key | a9daadad-b1ca-408b-b2c7-06a435328dce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premier REAMERS |
| Version Model Number | 9053037 |
| Company DUNS | 014789663 |
| Company Name | PREMIER DENTAL PRODUCTS COMPANY |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D6919053037 [Primary] |
| EKP | Reamer, Pulp Canal, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
[D6919053037]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-25 |
| Device Publish Date | 2023-10-17 |
| D6919053039 | WSL REAMERS PKG 6 25MM 45 |
| D6919053037 | WSL REAMERS PKG 6 25MM 35 |
| D6919053036 | REAMERS PKG 6 25MM 30 |
| D6919053035 | REAMERS PKG 6 25MM 25 |
| D6919053034 | REAMERS PKG 6 25MM 20 |
| D6919053033 | REAMERS PKG 6 25MM 15 |
| D6919053032 | REAMERS PKG 6 25MM 10 |
| D6919053031 | REAMERS PKG 6 25MM 08 |
| D6919053030 | REAMERS PKG 6 25MM 06 |
| D6919053004 | REAMERS PKG 6 21MM 20 |
| D6919053003 | REAMERS PKG 6 21MM 15 |
| D6919053002 | REAMERS PKG 6 21MM 10 |