| Primary Device ID | 00850440008919 |
| NIH Device Record Key | 28f6260c-8290-49f0-9767-274d4ec8f9f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TUN Ultrasonic Tip |
| Version Model Number | GB1-90 |
| Company DUNS | 079892178 |
| Company Name | Engineered Endodontics, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| 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 | 00850440008919 [Primary] |
| ELC | Scaler, Ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850440008919]
Dry Heat Sterilization
[00850440008919]
Dry Heat Sterilization
[00850440008919]
Dry Heat Sterilization
[00850440008919]
Dry Heat Sterilization
[00850440008919]
Dry Heat Sterilization
[00850440008919]
Dry Heat Sterilization
[00850440008919]
Dry Heat Sterilization
[00850440008919]
Dry Heat Sterilization
[00850440008919]
Dry Heat Sterilization
[00850440008919]
Dry Heat Sterilization
[00850440008919]
Dry Heat Sterilization
[00850440008919]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-12 |
| Device Publish Date | 2026-01-02 |
| 00850440008926 | TUN Ultrasonic Tip |
| 00850440008919 | TUN Ultrasonic Tip |
| 00850440008780 | TUN Ultrasonic Tip |
| 00850440008773 | TUN Ultrasonic Tip |
| 00850440008766 | TUN Ultrasonic Tip |
| 00850440008759 | TUN Ultrasonic Tip |
| 00850440008742 | TUN Ultrasonic Tip |
| 00850440008735 | TUN Ultrasonic Tip |
| 00850440008728 | TUN Ultrasonic Tip |
| 00850440008711 | TUN Ultrasonic Tip |
| 00850440008704 | TUN Ultrasonic Tip |
| 00850440008698 | TUN Ultrasonic Tip |
| 00850440008681 | TUN Ultrasonic Tip |
| 00850440008674 | TUN Ultrasonic Tip |
| 00850440008636 | TUN Ultrasonic Tip |
| 00850440008629 | TUN Ultrasonic Tip |
| 00850440008612 | TUN Ultrasonic Tip |
| 00850440008605 | TUN Ultrasonic Tip |
| 00850440008599 | TUN Ultrasonic Tip |
| 00850440008452 | TUN Ultrasonic Tip |
| 00850440008445 | TUN Ultrasonic Tip |
| 00850440008438 | TUN Ultrasonic Tip |
| 00850440008292 | TUN Ultrasonic Tip |
| 00850440008278 | TUN Ultrasonic Tip |
| 00850440008254 | TUN Ultrasonic Tip |
| 00850440008100 | TUN Ultrasonic Tip |
| 00850440008087 | TUN Ultrasonic Tip |
| 00850440008063 | TUN Ultrasonic Tip |
| 00850440008049 | TUN Ultrasonic Tip |
| 00850440008025 | TUN Ultrasonic Tip |
| 00850440008001 | TUN Ultrasonic Tip |