| Primary Device ID | 06947600304531 |
| NIH Device Record Key | 39312b0d-93ea-40f9-916b-6e63bc9ad086 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guide For BC BL RC System |
| Version Model Number | 153120 |
| 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 | 06947600304531 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06947600304531]
Moist Heat or Steam Sterilization
[06947600304531]
Moist Heat or Steam Sterilization
[06947600304531]
Moist Heat or Steam Sterilization
[06947600304531]
Moist Heat or Steam Sterilization
[06947600304531]
Moist Heat or Steam Sterilization
[06947600304531]
Moist Heat or Steam Sterilization
[06947600304531]
Moist Heat or Steam Sterilization
[06947600304531]
Moist Heat or Steam Sterilization
[06947600304531]
Moist Heat or Steam Sterilization
[06947600304531]
Moist Heat or Steam Sterilization
[06947600304531]
Moist Heat or Steam Sterilization
[06947600304531]
Moist Heat or Steam Sterilization
[06947600304531]
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 |
| 06947600304548 | 153130 |
| 06947600304531 | 153120 |