| Primary Device ID | 08056304450296 |
| NIH Device Record Key | 7905c1cb-0dea-49da-9b11-4694344440ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MyLabSix CrystallLine |
| Version Model Number | 100642500 |
| 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 | 08056304450296 [Primary] |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2025-12-15 |
| Device Publish Date | 2016-11-29 |
| 08056304450296 - MyLabSix CrystallLine | 2025-12-15Real Name MyLabSix CrystaLine |
| 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 |
| 08056304452924 - L 3-11 | 2025-12-15 |
| 08056304452931 - P 1-5 | 2025-12-15 |