| Primary Device ID | 08800019110903 |
| NIH Device Record Key | d52048e6-ae75-4ee1-adf6-7ca7d071107e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leetrac Wide handle |
| Version Model Number | LRTNH |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800019110903 [Primary] |
| EMO | Knife, Periodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
[08800019110903]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-23 |
| Device Publish Date | 2023-06-15 |
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| 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 |