| Primary Device ID | 00815212024511 |
| NIH Device Record Key | 5f923f6c-b030-474a-9a47-0ce8bd5c5b3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STRYKER SPHERES - 4 CT TYVEK |
| Version Model Number | 02145-001 |
| Company DUNS | 933506164 |
| Company Name | Izi Medical Products, LLC |
| 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 | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |