| Primary Device ID | 06970831726025 | 
| NIH Device Record Key | 9efebb49-da1d-4623-b8c8-725614cab94a | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Insighters | 
| Version Model Number | 3.5-inch Host | 
| Company DUNS | 551096917 | 
| Company Name | Shenzhen Insighters Medical Technology Co., Ltd. | 
| 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 | false | 
| Lot Batch | true | 
| Serial Number | true | 
| Manufacturing Date | true | 
| Expiration Date | true | 
| 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 | 06970831726025 [Primary] | 
| CCW | Laryngoscope, Rigid | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-01-13 | 
| Device Publish Date | 2023-01-05 | 
| 06970831720016 | iS3-R | 
| 06970831726032 | iS6-L Handle | 
| 06970831726025 | 3.5-inch Host | 
| 06970831723239 | insight iS6 | 
| 06970831726087 | Trolley iS-TC2 | 
| 06970831726070 | Trolley iS-TC1 | 
| 06970831723260 | iS-PF2 | 
| 06970831726162 | 3.5 inch Host (iS3) | 
| 06970831726186 | Power Adapter | 
| 06970831726179 | Handle (iS3) | 
| 06970831726063 | Power Adapter | 
| 06970831726056 | Connection Cable | 
| 06970831726049 | Wireless Module | 
| 06970831723253 | iS-PF1 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  INSIGHTERS  97693417  not registered Live/Pending | Insighters Inc 2022-11-28 | 
|  INSIGHTERS  88674991  not registered Live/Pending | Shenzhen Insighters Medical Technology Co., Ltd. 2019-10-31 |