| Primary Device ID | 00810014635736 |
| NIH Device Record Key | 7ababd22-9be8-4fc6-99f3-6463c4c8e01f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurgyFoam |
| Version Model Number | 780SP1 |
| Company DUNS | 142007082 |
| Company Name | U.S. SURGITECH INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 00810014635736 [Primary] |
| GS1 | 10810014635733 [Package] Package: [5 Units] In Commercial Distribution |
| CCX | Support, Patient Position |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-08 |
| Device Publish Date | 2023-07-31 |
| 00810014636832 - SurgyPad | 2024-10-18 SurgyPad with Integrated Adjustable Arms Protectors 36" |
| 10810014639908 - SurgyCut | 2024-10-18 SurgyCut Biopsy Forceps 1.8mm / 70cm |
| 00810014639918 - SurgyCut | 2024-10-18 SurgyCut Grasping Forceps 1.8mm / 70cm |
| 00810014635736 - SurgyFoam | 2023-08-08SurgyPad with Integrated Adjustable Arms Protectors |
| 00810014635736 - SurgyFoam | 2023-08-08 SurgyPad with Integrated Adjustable Arms Protectors |
| 00810014632582 - SurgyCut | 2023-06-22 SurgyCut Curved Blade with Suction & Electrode, 5mm/45cm |
| 00810014632612 - SurgyCut | 2023-06-22 SurgyCut Straight Blade Hand Control Electrode, 5mm/45cm |
| 00810014632162 - SurgyCut | 2023-06-19 SurgyCut J - Hook Foot Control Electrode, 5mm/45cm |
| 00810014632193 - SurgyCut | 2023-06-19 SurgyCut J - Hook with Handle Electrode, 5mm/45cm |