| Primary Device ID | 08056304452191 |
| NIH Device Record Key | 9943d84d-96da-4329-9acf-f2f1e49edbcf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TE122 |
| Version Model Number | 9600186000 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08056304452191 [Primary] |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-11-25 |
| Device Publish Date | 2016-09-27 |
| 08056304455826 - MyLabC25 | 2025-12-18 |
| 08056304455833 - MyLabC30 | 2025-12-18 |
| 08056304450296 - MyLabSix CrystallLine | 2025-12-15 Real Name MyLabSix CrystaLine |
| 08056304452597 - MyLabSeven | 2025-12-15 Version V2 |
| 08056304452603 - MyLabEight eXP | 2025-12-15 |
| 08056304452610 - MyLabEight | 2025-12-15 |
| 08056304452658 - MyLab 9 eXP | 2025-12-15 |
| 08056304452917 - C 1-8 | 2025-12-15 |