US-Litho
ULTRASOUND GENERATOR for urological intracorporeal lithotripsy, U: 120-127VAC, 50/60Hz, Dim. (wxhxd): 320x105x360mm
1manufacturer
11catalogue 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 | 2016-09-23 |
| Record revised | 2024-02-29 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Outer diameter 1.5 to 28.5 mm; length 145 to 564 mm |
| Distribution end date | 2024-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8959515 | Outer Diameter 1.5 mm | Withdrawn |
| 8962524 | Outer Diameter 2.4 mm | Withdrawn |
| 8954519 | Outer Diameter 1.9 mm | Withdrawn |
| 8962641 | Outer Diameter 4 mm | Withdrawn |
| 8962541 | Length 360 mm | Withdrawn |
| 8963535 | Length 358 mm | Withdrawn |
| 2271501 | Length 145 mm | Withdrawn |
| 8962519 | Length 361 mm | Withdrawn |
| 8963635 | Length 370 mm | Withdrawn |
| 2271004 | Withdrawn | |
| 8954515 | Length 564 mm | Withdrawn |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 |
| Riwolith | Richard Wolf Gmbh | 14 |
| Lithotriptor, Electro-Hydraulic | Karl Storz GmbH & Co. KG | 12 |
| 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.