StoneBreaker
StoneBreaker Single Use Probe 1.0mm/500mm
1manufacturer
7catalogue numbers in this listing
7recalls on this code
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 | Cook Incorporated, United States |
|---|---|
| FDA product code | FFK |
| Device type | Lithotriptor, Electro-Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4480 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2023-07-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Packaging | Pack of 5, pack of 10 |
| Distribution end date | 2018-03-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G52607 | In distribution | |
| G52603 | In distribution | |
| G52608 | In distribution | |
| G52605 | In distribution | |
| G52609 | In distribution | |
| G52606 | In distribution | |
| G52604 | Withdrawn |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 |
| 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 |
| 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
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-01-31 | Class II | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. | 470 | 2020-04-17 |
| 2018-01-31 | Class II | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. | 370 | 2020-04-17 |
| 2018-01-31 | Class II | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. | 760 | 2020-04-17 |
| 2018-01-31 | Class II | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. | 12,556 | 2020-04-17 |
| 2018-01-31 | Class II | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. | 38,542 | 2020-04-17 |
| 2018-01-31 | Class II | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. | 629 | 2020-04-17 |
| 2018-01-31 | Class II | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. | 751 | 2020-04-17 |
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.