| Primary Device ID | 00855279005108 |
| NIH Device Record Key | 30cf1ba9-1d38-4342-8c44-32300d788ae7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lithotripsy Power Cord ShockPulse SE |
| Version Model Number | SPL-PC |
| 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 | false |
| 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 | 00855279005108 [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 |
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| 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 |