| Primary Device ID | 00855279005061 |
| NIH Device Record Key | 5c5b1a84-68cc-4ace-8113-b3217630294d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lithotripsy Footswitch ShockPulse-SE |
| Version Model Number | SPL-FS |
| Company DUNS | 943561522 |
| Company Name | CYBERSONICS 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855279005061 [Primary] |
| FEO | Lithotriptor, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-30 |
| H891CWRBPBX3 - CyberWand Probe Set | 2018-07-06 |
| H891CWUSLFS2 - CyberWand USL Foot Switch | 2018-07-06 |
| H891CWUSLG2 - CyberWand USL Generator | 2018-07-06 |
| H891CWUSLNC2 - CyberWand USL NoseCone Kit | 2018-07-06 |
| H891CWUSLPC2 - CyberWand USL Power Cord | 2018-07-06 |
| H891CWUSLSA4 - CyberWand USL Ultrasonic Lithotripsy System | 2018-07-06 |
| H891CWUSLTA2 - CyberWand USL Advanced Transducer | 2018-07-06 |
| H891CWUSLW2 - Cyberwand USL Wrench | 2018-07-06 |