| Primary Device ID | 06934955942150 |
| NIH Device Record Key | 8342ec4c-5a0f-46d8-9401-abf96666e381 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sapphire II Pro |
| Version Model Number | 217-203-5UU |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06934955942150 [Primary] |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-25 |
| Device Publish Date | 2023-05-17 |
| 06934955942457 | Balloon Dilatation Catheter |
| 06934955942440 | Balloon Dilatation Catheter |
| 06934955942433 | Balloon Dilatation Catheter |
| 06934955942426 | Balloon Dilatation Catheter |
| 06934955942419 | Balloon Dilatation Catheter |
| 06934955942402 | Balloon Dilatation Catheter |
| 06934955942396 | Balloon Dilatation Catheter |
| 06934955942389 | Balloon Dilatation Catheter |
| 06934955942372 | Balloon Dilatation Catheter |
| 06934955942365 | Balloon Dilatation Catheter |
| 06934955942358 | Balloon Dilatation Catheter |
| 06934955942341 | Balloon Dilatation Catheter |
| 06934955942334 | Balloon Dilatation Catheter |
| 06934955942327 | Balloon Dilatation Catheter |
| 06934955942310 | Balloon Dilatation Catheter |
| 06934955942303 | Balloon Dilatation Catheter |
| 06934955942297 | Balloon Dilatation Catheter |
| 06934955942280 | Balloon Dilatation Catheter |
| 06934955942273 | Balloon Dilatation Catheter |
| 06934955942266 | Balloon Dilatation Catheter |
| 06934955942259 | Balloon Dilatation Datheter |
| 06934955942242 | Balloon Dilatation Catheter |
| 06934955942235 | Balloon Dilatation Catheter |
| 06934955942228 | Balloon Dilatation Catheter |
| 06934955942211 | Balloon Dilatation Catheter |
| 06934955942204 | Balloon Dilatation Catheter |
| 06934955942198 | Balloon Dilatation Catheter |
| 06934955942181 | Balloon Dilatation Catheter |
| 06934955942174 | Balloon Dilatation Catheter |
| 06934955942167 | Balloon Dilatation Catheter |
| 06934955942136 | Balloon Dilatation Catheter |
| 06934955942129 | Balloon Dilatation Catheter |
| 06934955942112 | Balloon Dilatation Catheter |
| 06934955942105 | Balloon Dilatation Catheter |
| 06934955942099 | Balloon Dilatation Catheter |
| 06934955942082 | Balloon Dilatation Catheter |
| 06934955942075 | Balloon Dilatation Catheter |
| 06934955942068 | Balloon Dilatation Catheter |
| 06934955942051 | Balloon Dilatation Catheter |
| 06934955942044 | Balloon Dilatation Catheter |
| 06934955942037 | Balloon Dilatation Catheter |
| 06934955942020 | Balloon Dilatation Catheter |
| 06934955942013 | Balloon Dilatation Catheter |
| 06934955942150 | Balloon Dilatation Catheter |
| 06934955942143 | Balloon Dilatation Catheter |