| Primary Device ID | 06934955936302 |
| NIH Device Record Key | 1b78cfe4-08d0-4366-be9d-15021b3c4035 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Scoreflex NC Scoring PTCA Catheter |
| Version Model Number | 620-204-1U |
| 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 | 06934955936302 [Primary] |
| NWX | Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-24 |
| Device Publish Date | 2022-02-16 |
| 06934955936487 | 640-204-1U |
| 06934955936470 | 640-154-1U |
| 06934955936463 | 640-104-1U |
| 06934955936456 | 635-204-1U |
| 06934955936449 | 635-154-1U |
| 06934955936432 | 635-104-1U |
| 06934955936425 | 630-204-1U |
| 06934955936418 | 630-154-1U |
| 06934955936401 | 630-104-1U |
| 06934955936395 | 627-204-1U |
| 06934955936388 | 627-154-1U |
| 06934955936371 | 627-104-1U |
| 06934955936364 | 625-204-1U |
| 06934955936357 | 625-154-1U |
| 06934955936340 | 625-104-1U |
| 06934955936333 | 622-204-1U |
| 06934955936326 | 622-154-1U |
| 06934955936319 | 622-104-1U |
| 06934955936302 | 620-204-1U |
| 06934955936296 | 620-154-1U |
| 06934955936289 | 620-104-1U |
| 06934955936272 | 617-204-1U |
| 06934955936265 | 617-154-1U |
| 06934955936258 | 617-104-1U |