| Primary Device ID | 06934955905186 |
| NIH Device Record Key | be9ea153-8b5c-4b51-b2cf-0d46c80dd1c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sapphire NC 24 Coronary Dilatation Catheter |
| Version Model Number | 492001212 |
| Company DUNS | 530923226 |
| Company Name | OrbusNeich Medical (ShenZhen) Co., 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 | 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 |