| Primary Device ID | 06934955933196 |
| NIH Device Record Key | d18afbd6-3fa0-4598-bf3c-f687feaac315 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW |
| Version Model Number | 6080-080-12 |
| Catalog Number | 6080-080-12 |
| 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 | |
| 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 | |
| Phone | 13128973283 |
| gxia@orbusneich.com | |
| Phone | 13128973283 |
| gxia@orbusneich.com | |
| Phone | 13128973283 |
| gxia@orbusneich.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06934955933196 [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 | 2024-08-19 |
| Device Publish Date | 2024-08-10 |
| 06934955934377 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934360 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934353 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934346 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934339 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934322 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934315 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934308 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934292 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934285 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934278 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934261 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934254 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934247 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934230 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934223 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934216 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934209 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934193 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934186 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934179 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934162 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934155 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934148 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934131 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934124 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934100 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934094 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934087 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934070 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934063 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934056 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934049 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934032 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934025 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934018 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955934001 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955933998 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955933981 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955933974 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955933967 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955933950 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955933943 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955933936 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955933929 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955933912 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955933905 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955933899 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955933882 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955933875 | Percutaneous Transluminal Angioplasty Balloon Catheter |