Riwolith
PROBE 3.3FR WL 1050MM PACK=3 PCS, sterile, for single use
1manufacturer
14catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
Record
| Listed by | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | FFK |
| Device type | Lithotriptor, Electro-Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4480 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2017-06-28 |
| Record revised | 2025-01-23 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 0 to 70 % RH; Storage environment temperature 5 to 30 °C |
| Sizes | Length 470 to 1050 mm; outer diameter 0.8 to 3 mm |
| Distribution end date | 2024-12-20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2280333 | Length 700 mm | 3 | Withdrawn |
| 2280233 | Length 1050 mm | 3 | Withdrawn |
| 2280991 | Withdrawn | ||
| 21371505 | 5 | Withdrawn | |
| 2280423 | Outer Diameter 0.8 mm | 3 | Withdrawn |
| 2280093 | 3 | Withdrawn | |
| 2280323 | Outer Diameter 0.8 mm | 3 | Withdrawn |
| 22800915 | Length 470 mm | 5 | Withdrawn |
| 2280433 | Length 1050 mm | 3 | Withdrawn |
| 2280123 | Outer Diameter 0.8 mm | 3 | Withdrawn |
| 2280153 | Length 770 mm | 3 | Withdrawn |
| 2280133 | Outer Diameter 1.1 mm | 3 | Withdrawn |
| 22801515 | 5 | Withdrawn | |
| 2280223 | Length 1050 mm | 3 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lithoclast | E.M.S. Electro Medical Systems S.A. | 73 |
| Calcusplit | Karl Storz GmbH & Co. KG | 22 |
| Lithotriptor, Electro-Hydraulic | Karl Storz GmbH & Co. KG | 12 |
| US-Litho | Richard Wolf Gmbh | 11 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 11 |
| Lithotriptor, Electro-Hydraulic | Richard Wolf Gmbh | 9 |
| EHL-Probe | Walz Elektronik Gmbh | 8 |
| Autolith Touch | Northgate Technologies Inc. | 7 |
| StoneBreaker | Cook Incorporated | 7 |
| Swiss LithoClast Select | E.M.S. Electro Medical Systems S.A. | 5 |
| Rigid Pneumatic Probe | Boston Scientific Corporation | 5 |
| Ultrasound Probe | Boston Scientific Corporation | 4 |
Showing 12 of 73. All products under Lithotriptor, Electro-Hydraulic
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.