Piranha
ROTATIONS-MORCELLATOR Ø 4.8MM WL 385MM for MORCESCOPE Storz, for morcellation following laser prostate enucleation, sterile
5manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Guangzhou Kaiheng K&S Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Jiangxi Sanxin Medtec Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
| Bain Medical Equipment(Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 3 |
| Vital Healthcare (Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | FJK |
| Device type | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5820 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2017-06-28 |
| Record revised | 2018-12-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Hydrogen Peroxide, Ethylene Oxide |
| Supplied sterile | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 30 °C; Storage environment humidity 0 to 70 % RH |
| Sizes | Length 335 to 385 mm; outer diameter 4.8 mm |
| Distribution end date | 2017-06-29 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 49700103 | Length 385 mm | 3 | Withdrawn |
| 49700113 | Length 335 mm | 3 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 58 |
| Nipro SET Blood Tubing SET With Transducer Protectors AND Priming SET | Nipro Medical Corporation | 12 |
| Hemodialysis Bloodlines | B. Braun Medical Inc. | 12 |
| CombiSet | Fresenius Medical Care | 11 |
| Cartridge Blood Set | Gambro Renal Products S.A. DE C.V. | 8 |
| 5008X | Fresenius Medical Care Renal Therapies Group, LLC | 7 |
| Sunder | Sunder Biomedical Tech. Co., Ltd. | 6 |
| Streamline Airless System Set with Locksite Needleless Access Sites | Medisystems Corp. | 5 |
| Tablo(R) Cartridge | Outset Medical, Inc. | 5 |
| NovaLine | Bain Medical Equipment(Guangzhou) Co., Ltd. | 5 |
| Medisystems Hemodialysis Blood Tubing Sets | Medisystems Corp. | 4 |
| Diapact® | B. Braun Medical Inc. | 4 |
Showing 12 of 44. All products under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
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.