| Primary Device ID | 06947600316756 |
| NIH Device Record Key | 8d6a759d-6916-4455-9a26-009568b45ad9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Regular Guide |
| Version Model Number | 353100 |
| 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 | 06947600316756 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06947600316756]
Moist Heat or Steam Sterilization
[06947600316756]
Moist Heat or Steam Sterilization
[06947600316756]
Moist Heat or Steam Sterilization
[06947600316756]
Moist Heat or Steam Sterilization
[06947600316756]
Moist Heat or Steam Sterilization
[06947600316756]
Moist Heat or Steam Sterilization
[06947600316756]
Moist Heat or Steam Sterilization
[06947600316756]
Moist Heat or Steam Sterilization
[06947600316756]
Moist Heat or Steam Sterilization
[06947600316756]
Moist Heat or Steam Sterilization
[06947600316756]
Moist Heat or Steam Sterilization
[06947600316756]
Moist Heat or Steam Sterilization
[06947600316756]
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 |
| 06947600316763 | 353110 |
| 06947600316756 | 353100 |