| Primary Device ID | 08056304455062 |
| NIH Device Record Key | dadc962a-88a0-45fa-9932-bbea6326f3ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 2CWL |
| Version Model Number | 120000106 |
| Company DUNS | 437384304 |
| Company Name | ESAOTE SPA |
| 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 | 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 | 08056304455062 [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 | 2025-07-15 |
| Device Publish Date | 2025-07-07 |
| 08056304455017 - MyLabA50 | 2025-07-15 |
| 08056304455062 - 2CWL | 2025-07-15 |
| 08056304455062 - 2CWL | 2025-07-15 |
| 08056304455079 - 5CWL | 2025-07-15 |
| 08056304455215 - MyLabE85 | 2025-07-15 |
| 08056304455222 - P 1-5E | 2025-07-15 |
| 08056304455239 - C 1-8E | 2025-07-15 |
| 08056304455307 - MyLabA70 | 2025-07-15 |
| 08056304455383 - L 3-15E | 2025-07-15 |