| Primary Device ID | 00855279005160 |
| NIH Device Record Key | 5b93e73f-fdd2-4dde-a579-622e43f8af7b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 2.9 Fr (0.97mm) X 578mm |
| Version Model Number | SPL-PD097 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855279005160 [Primary] |
| GS1 | 10855279005167 [Package] Package: [3 Units] In Commercial Distribution |
| FEO | Lithotriptor, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| 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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