| Primary Device ID | 08800019140818 |
| NIH Device Record Key | a68935ae-5d7a-4b3e-a279-02121d1bc59e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Digit R |
| Version Model Number | DGR |
| Company DUNS | 687338285 |
| Company Name | B& L Biotech, inc. |
| 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 | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800019140818 [Primary] |
| EKS | File, Pulp Canal, Endodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-14 |
| Device Publish Date | 2022-12-06 |
| 08800019151012 - BL Clamp | 2025-07-28 |
| 08800019151029 - BL Clamp | 2025-07-28 |
| 08800019151036 - BL Clamp | 2025-07-28 |
| 08800019151043 - BL Clamp | 2025-07-28 |
| 08800019151050 - BL Clamp | 2025-07-28 |
| 08800019151067 - BL Clamp | 2025-07-28 |
| 08800019116608 - NeoGlide Resin Instruments | 2025-06-26 |
| 08800019116615 - NeoGlide Resin Instruments | 2025-06-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DIGIT R 90420696 not registered Live/Pending |
B&L BIOTECH, INC. 2020-12-28 |