| Primary Device ID | 06934955929809 |
| NIH Device Record Key | a2b2e1af-792d-4d85-9013-58b8e21031fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW |
| Version Model Number | 5820-180-12 |
| Catalog Number | 5820-180-12 |
| 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 |
| Phone | 13128973283 |
| gxia@orbusneich.com | |
| Phone | 13128973283 |
| gxia@orbusneich.com | |
| Phone | 13128973283 |
| gxia@orbusneich.com | |
| Phone | 13128973283 |
| gxia@orbusneich.com | |
| Phone | 13128973283 |
| gxia@orbusneich.com | |
| Phone | 13128973283 |
| gxia@orbusneich.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06934955929809 [Primary] |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-18 |
| Device Publish Date | 2024-07-10 |
| 06934955930911 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930904 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930898 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930881 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930874 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930867 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930850 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930843 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930836 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930829 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930812 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930805 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930799 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930782 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930775 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930768 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930751 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930744 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930737 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930720 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930713 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930706 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930690 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930683 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930676 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930669 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930652 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930645 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930638 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930621 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930614 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930607 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930591 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930584 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930577 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930560 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930553 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930546 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930539 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930522 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930515 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930508 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930492 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930485 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930478 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930461 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930454 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930447 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930430 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955930423 | Percutaneous Transluminal Angioplasty Balloon Catheter |