| Primary Device ID | 16970831723311 | 
| NIH Device Record Key | 5a320b7a-efc9-4602-a92a-28fb769c8080 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Insighter | 
| Version Model Number | i6-SS | 
| 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 | 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 | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 06970831723314 [Primary] | 
| GS1 | 16970831723311 [Package] Contains: 06970831723314 Package: [20 Units] In Commercial Distribution | 
| GS1 | 26970831723318 [Package] Package: [5 Units] In Commercial Distribution | 
| LRC | Instrument, Ent Manual Surgical | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-01-13 | 
| Device Publish Date | 2023-01-05 | 
| 06970831725943 | iS-LMA-A 50 | 
| 06970831725936 | iS-LMA-A 40 | 
| 06970831725929 | iS-LMA-A 30 | 
| 06970831723390 | Standard type 6Fr | 
| 16970831723342 | i6-L | 
| 16970831723335 | i6-M | 
| 16970831723328 | i6-S | 
| 16970831723311 | i6-SS | 
| 16970831723304 | L | 
| 16970831723298 | M | 
| 16970831723281 | S | 
| 16970831723274 | SS | 
| 06970831723192 | iS3-C | 
| 06970831723154 | iS3-F | 
| 06970831723017 | insight ST1 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  INSIGHTER  98316038  not registered Live/Pending | LIGHT FACTORY CREATIVE TECHNOLOGY PTE. LTD. 2023-12-15 | 
|  INSIGHTER  90695556  not registered Live/Pending | Yu Zhilei 2021-05-07 | 
|  INSIGHTER  86648977  not registered Dead/Abandoned | Lytx, Inc. 2015-06-02 | 
|  INSIGHTER  79200496  5388794 Live/Registered | Guangzhou Insighter Biotechnology Co., Ltd. 2016-12-19 | 
|  INSIGHTER  79179762  5084254 Live/Registered | Guangzhou Insighter Biotechnology Co., Ltd. 2015-10-12 | 
|  INSIGHTER  77042460  3284810 Dead/Cancelled | NETWORKED INSIGHTS, INC. 2006-11-13 | 
|  INSIGHTER  76104362  2689786 Dead/Cancelled | PhoCusWright, Inc. 2000-08-07 |