Z-MED™
PDZ370 Special Z-MED 16X6X100
5manufacturers in China registered for this device type
62catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Kossel Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | B. Braun Interventional Systems, Inc., United States |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| 510(k) | K122012 |
| Record published | 2016-08-09 |
| Record revised | 2023-09-07 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: Store at room temp |
| Distribution end date | 2021-08-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 611808 | In distribution | |
| 610243 | Length : 60.000 MM | In distribution |
| 611695 | In distribution | |
| 611681 | In distribution | |
| 611652 | Length : 20.000 MM | In distribution |
| 610235 | Length : 40.000 MM | In distribution |
| 611803 | In distribution | |
| 611806 | In distribution | |
| 610460 | In distribution | |
| 611674 | In distribution | |
| 612061 | In distribution | |
| 611555 | In distribution | |
| 611687 | In distribution | |
| 611817 | In distribution | |
| 611786 | In distribution | |
| 611820 | In distribution | |
| 611650 | In distribution | |
| 610478 | In distribution | |
| 611677 | In distribution | |
| 611565 | In distribution | |
| 611813 | In distribution | |
| 611784 | In distribution | |
| 610482 | In distribution | |
| 611669 | In distribution | |
| 611683 | In distribution | |
| 610466 | In distribution | |
| 610467 | In distribution | |
| 610447 | In distribution | |
| 610459 | In distribution | |
| 610476 | In distribution | |
| 612060 | In distribution | |
| 610232 | In distribution | |
| 611676 | In distribution | |
| 611812 | In distribution | |
| 611815 | In distribution | |
| 611560 | In distribution | |
| 610477 | In distribution | |
| 611672 | In distribution | |
| 610498 | In distribution | |
| 611809 | In distribution | |
| 610458 | In distribution | |
| 611678 | In distribution | |
| 611816 | In distribution | |
| 610239 | Length : 30.000 MM | In distribution |
| 610486 | In distribution | |
| 611823 | In distribution | |
| 610457 | In distribution | |
| 611554 | In distribution | |
| 611819 | In distribution | |
| 610475 | In distribution | |
| 611818 | In distribution | |
| 610233 | In distribution | |
| 611787 | In distribution | |
| 610491 | In distribution | |
| 610453 | Withdrawn | |
| 610451 | Withdrawn | |
| 611696 | Withdrawn | |
| 610454 | Withdrawn | |
| 610464 | Withdrawn | |
| 611785 | Withdrawn | |
| 610452 | Withdrawn | |
| 611477 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Parafleet SC 018 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 1,460 |
| Jade Plus PTA Balloon Dilatation Catheter / Jade Plus 18 OTW | OrbusNeich Medical (Shenzhen) Co., Ltd. | 832 |
| Jade PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 667 |
| Parafleet SC 014 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 572 |
| Minerva PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 504 |
| Advocate | Arravasc, Ltd. | 441 |
| Ultraverse® 035 PTA Dilatation Catheter | Bard Peripheral Vascular, Inc. | 361 |
| Polux PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 359 |
| Advance | Cook Incorporated | 355 |
| Pacific™ Plus | Medtronic, Inc. | 347 |
| EverCross™ | ev3, Inc. | 316 |
| Achilles NC PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 297 |
Showing 12 of 167. All products under Catheter, Angioplasty, Peripheral, Transluminal
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.