| Primary Device ID | 06934955937460 |
| NIH Device Record Key | ee9e7da2-d6e0-4453-969d-5b68cdf1d607 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW |
| Version Model Number | 5955-180-12 |
| Catalog Number | 5955-180-12 |
| 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 | |
| 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 | 06934955937460 [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 | 2024-08-05 |
| Device Publish Date | 2024-07-27 |
| 06934955937415 | Percutaneous Transluminal Angioplasty Balloon Cathet |
| 06934955937408 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937392 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937385 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937378 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937361 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937354 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937347 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937330 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937323 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937316 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937309 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937293 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937286 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937279 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937262 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937255 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937248 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937231 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937224 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937217 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937200 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937194 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937187 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937170 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937163 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937156 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937149 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937132 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937125 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937118 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937101 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937095 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937088 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937071 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937064 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937057 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937040 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937026 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937019 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955937002 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955936999 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955936982 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955936975 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955936968 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955936951 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955936944 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955936937 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955936920 | Percutaneous Transluminal Angioplasty Balloon Catheter |
| 06934955936913 | Percutaneous Transluminal Angioplasty Balloon Catheter |