| Primary Device ID | 07290016787597 |
| NIH Device Record Key | 4975256e-9555-4ffa-9643-3cdd81b8c6a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spherodon M |
| Version Model Number | O-120309 |
| Catalog Number | O-120309 |
| Company DUNS | 600071344 |
| Company Name | SILMET LTD |
| 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 | false |
| 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 |