| Primary Device ID | 08720387388127 |
| NIH Device Record Key | 18e1b9cb-7e01-4661-be54-5b038cdb0f52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AFCS PEARLS™ Control unit |
| Version Model Number | SAT2 |
| Catalog Number | 2010312 |
| Company DUNS | 417294923 |
| Company Name | Synergie Nederland B.V. |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |