| Primary Device ID | 00810014631875 |
| NIH Device Record Key | 7bbaf460-879d-467d-ba83-c2c4f7f3d73c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurgyCut |
| Version Model Number | 790-201-535 |
| Catalog Number | 790-201-535 |
| Company DUNS | 142007082 |
| Company Name | U.S. SURGITECH INC. |
| 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 | true |
| 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 | 00810014631851 [Primary] |
| GS1 | 00810014631868 [Package] Contains: 00810014631851 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 00810014631875 [Package] Contains: 00810014631851 Package: Box [100 Units] In Commercial Distribution |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-28 |
| Device Publish Date | 2019-03-20 |
| 00810014631967 | SurgyCut Disposable Hook Scissor Shaft, 5mm/35cm |
| 00810014631127 | SurgyCut J - Hook Hand Control Electrode, 5mm/35cm |
| 00810014631028 | SurgyCut L - Hook Foot Control Electrode, 5mm/35cm |
| 00810014631080 | 790-103-535 |
| 00810014632872 | 790-201-545 |
| 00810014631974 | 790-205-535 |
| 00810014633398 | SurgyCut Vertical Reusable Scissor Handle |
| 00810014632520 | SurgyCut Curved Blade Foot Control Electrode, 5mm/45cm |
| 00810014632506 | SurgyCut Curved Blade Hand Control Electrode, 5mm/45cm |
| 00810014632056 | 790-101-545 |
| 00810014632025 | 790-100-545 |
| 00810014631936 | SurgyCut Fully Disposable Mini Scissor, 5mm/35cm |
| 00810014631905 | SurgyCut Disposable Mini Scissor Shaft, 5mm/35cm |
| 00810014631875 | SurgyCut Fully Disposable Scissor, 5mm/35cm |
| 00810014631844 | SurgyCut Disposable Scissor Shaft, 5mm/35cm |
| 00810014631813 | SurgyCut Spatula with Suction & Electrode, 5mm/35cm |
| 00810014631783 | SurgyCut Spatula with Handle Electrode, 5mm/35cm |
| 00810014631752 | 790-125-535 |
| 00810014631721 | 790-124-535 |
| 00810014631639 | 790-121-535 |
| 00810014631608 | 790-120-535 |
| 00810014631509 | SurgyCut Curved Blade Foot Control Electrode, 5mm/35cm |
| 00810014631486 | SurgyCut Curved Blade Hand Control Electrode, 5mm/35cm |
| 00810014631455 | SurgyCut J - Wire with Suction & Electrode, 5mm/35cm |
| 00810014631424 | SurgyCut J - Wire with Handle Electrode, 5mm/35cm |
| 00810014631394 | 790-113-535 |
| 00810014631363 | 790-112-535 |
| 00810014631332 | SurgyCut L - Wire with Suction & Electrode, 5mm/35cm |
| 00810014631301 | SurgyCut L - Wire with Handle Electrode, 5mm/35cm |
| 00810014631257 | 790-109-535 |
| 00810014631240 | 790-108-535 |
| 00810014631158 | 790-105-535 |
| 00810014631004 | 790-100-535 |
| 10810014635184 | SurgyCut Colorado Needle Hand Control Electrode 5mm / 45cm |
| 00810014631684 | SurgyCut Straight Blade with Suction & Electrode, 5mm/35cm |
| 00810014631653 | SurgyCut Straight Blade with Handle Electrode, 5mm/35cm |
| 00810014631561 | SurgyCut Curved Blade with Suction & Electrode, 5mm/35cm |
| 00810014631530 | SurgyCut Curved Blade with Handle Electrode, 5mm/35cm |
| 00810014631202 | SurgyCut J - Hook with Suction & Electrode, 5mm/35cm |
| 00810014631172 | SurgyCut J - Hook with Handle Electrode, 5mm/35cm |
| 00810014632131 | SurgyCut J - Hook Hand Control Electrode, 5mm/45cm |
| 00810014632100 | SurgyCut L - Hook with Suction & Electrode, 5mm/45cm |
| 00810014632070 | SurgyCut L - Hook with Handle Electrode, 5mm/45cm |
| 00810014631059 | SurgyCut L - Hook with Handle Electrode, 5mm/35cm |
| 00810014633008 | SurgyCut Fully Disposable Hook Scissor, 5mm/45cm |
| 00810014632315 | SurgyCut L - Wire with Handle Electrode, 5mm/45cm |
| 00810014632285 | SurgyCut L - Wire Foot Control Electrode, 5mm/45cm |
| 00810014632254 | SurgyCut L - Wire Hand Control Electrode, 5mm/45cm |
| 00810014632971 | SurgyCut Disposable Hook Scissor Shaft, 5mm/45cm |
| 00810014632940 | SurgyCut Fully Disposable Mini Scissor, 5mm/45cm |