| Primary Device ID | 08683105129344 |
| NIH Device Record Key | 70218199-f54e-4127-86b4-67f1e9b9d938 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Puresense Med |
| Version Model Number | PSM103-XL |
| Company DUNS | 533154912 |
| Company Name | PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |