| Primary Device ID | 08056304454621 |
| NIH Device Record Key | 25cc256b-b996-404b-ab9d-486d1a9b35c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 5CWS-L |
| Version Model Number | 120000104 |
| Company DUNS | 437384304 |
| Company Name | ESAOTE SPA |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08056304454621 [Primary] |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-22 |
| Device Publish Date | 2023-12-14 |
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| 08056304453419 - MyLabX8 | 2024-11-25 |
| 08056304454126 - MyLabX8 eXP | 2024-11-25 |
| 08056304455727 - G-scan Open | 2024-07-10 |
| 08056304455741 - O-scan Smart | 2024-07-10 |