| Primary Device ID | 06947600319788 |
| NIH Device Record Key | a8893896-6e13-4689-a79d-a38664dbed93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trephine Drill |
| Version Model Number | 352410 |
| Company DUNS | 527603266 |
| Company Name | BIO CONCEPT Co., Ltd. |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06947600319788 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06947600319788]
Moist Heat or Steam Sterilization
[06947600319788]
Moist Heat or Steam Sterilization
[06947600319788]
Moist Heat or Steam Sterilization
[06947600319788]
Moist Heat or Steam Sterilization
[06947600319788]
Moist Heat or Steam Sterilization
[06947600319788]
Moist Heat or Steam Sterilization
[06947600319788]
Moist Heat or Steam Sterilization
[06947600319788]
Moist Heat or Steam Sterilization
[06947600319788]
Moist Heat or Steam Sterilization
[06947600319788]
Moist Heat or Steam Sterilization
[06947600319788]
Moist Heat or Steam Sterilization
[06947600319788]
Moist Heat or Steam Sterilization
[06947600319788]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-02 |
| Device Publish Date | 2025-03-25 |
| 06947600319856 | 352480 |
| 06947600319849 | 352470 |
| 06947600319832 | 352460 |
| 06947600319825 | 352450 |
| 06947600319818 | 352440 |
| 06947600319801 | 352430 |
| 06947600319795 | 352420 |
| 06947600319788 | 352410 |
| 06947600319771 | 352400 |
| 06947600319764 | 352390 |
| 06947600319757 | 352380 |
| 06947600316626 | 352490 |