| Primary Device ID | 00858276007724 |
| NIH Device Record Key | 22fd3425-2464-46d3-a8a4-1f8b79bbd1be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bite Block Adult |
| Version Model Number | MDBB1AY001A |
| Company DUNS | 079873914 |
| Company Name | Micro-tech Usa |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858276007717 [Primary] |
| GS1 | 00858276007724 [Package] Contains: 00858276007717 Package: Box [100 Units] In Commercial Distribution |
| GS1 | 00858276007731 [Package] Package: Case [8 Units] In Commercial Distribution |
| MNK | Endoscopic Bite Block |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-11 |
| Device Publish Date | 2025-03-03 |
| 10850025860854 - CO2 Source Tubing Adapter Olympus UCR | 2025-05-20 CO2 Source Tubing Adapter, Olympus UCR CO2 Insufflator, Non-Sterile. |
| 10850025860861 - CO2 Source Tubing Adapter Fuji GW100 | 2025-05-20 CO2 Source Tubing Adapter, Fuji GW100 CO2 Insufflator, Non-Sterile. |
| 10850025860908 - CO2 Source Tubing Filter Adapter Olympus | 2025-05-20 CO2 Source Tubing Filter Adapter Olympus, Sterile, Single Day Use. |
| 10858276007974 - CO2 Source Tubing Filter Olympus | 2025-05-20 CO2 Source Tubing Filter Olympus, Sterile, Single Day Use. |
| 10858276007981 - Endoscopy Kit - Compliance+ FUJ5 Kit | 2025-05-20 Endoscopy Kit, Compliance+, Sterile Lube 1.4oz, Gauze, Basin, FUJ5 Valve Set, Pad, Single Use |
| 10850025860809 - Scope Tip Protector | 2025-03-19 Distal Tip Protector Small |
| 10850025860816 - Scope Tip Protector | 2025-03-19 Distal Tip Protector Large |
| 00850025860437 - Irrigation Tubing Set | 2025-03-17 Irrigation Tubing Set |