EHL-Probe
- Primary DI
- 04260667540134
- Brand
- EHL-Probe
- Company
- Walz Elektronik GmbH
- Model
- P303000SST
- Device description
- Diamaeter of 3 Fr. with a length of 3 meter. Proximally reinforced.
- Published
- 2023-10-25
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| FFK | Lithotriptor, Electro-Hydraulic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K230488 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04260667540134 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04260667540134 | 04260667540134 | 4260667540134 |
GMDN Terms
| Term | Definition |
|---|---|
| Electrohydraulic lithotripsy system | An assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. It typically comprises a generator-powered probe which fires energy pulses at the stone's centre while the probe is irrigated with a saline solution. The collapse of the resulting plasma bubble causes a hydraulic shock that fragments the stone into several pieces which can then be removed using surgical instruments (e.g., a grasping instrument or stone basket). |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 320414030
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04260667540011 | EL27-Compact | EL27C115VEHL | 2023-10-25 | |
| 04260667540059 | EHL-Probe | P243000SST | 2023-10-25 | |
| 04260667540097 | EHL-Probe | P243000FST | 2023-10-25 | |
| 04260667540110 | EHL-Probe | P30950FST | 2023-10-25 | |
| 04260667540158 | EHL-Probe | P303000FST | 2023-10-25 | |
| 04260667540172 | EHL-Probe | P45600FST | 2023-10-25 | |
| 04260667540196 | EHL-Probe | P453000FST | 2023-10-25 | |
| 04260667540219 | EHL-Probe | P70450FST | 2023-10-25 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06973204210763 | Electrohydraulic Lithotriptor | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | FFK | 2025-06-26 |
| 06973204210787 | EHL Probe | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | FFK | 2025-06-26 |
| 06973204210794 | EHL Probe | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | FFK | 2025-06-26 |
| 06973204210800 | EHL Probe | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | FFK | 2025-06-26 |
| 00821925043596 | CYBERWAND | Gyrus Acmi, Inc. | FFK | 2024-07-25 |
| 07613353221836 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2024-03-20 |
| 07613353311568 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2024-03-20 |
| 07613353311575 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2024-03-20 |
| 07613353176686 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2024-03-20 |
| 07613353312046 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2024-03-20 |
| 07613353214203 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2023-11-22 |
| 04260667540011 | EL27-Compact | Walz Elektronik GmbH | FFK | 2023-10-25 |
| 04260667540059 | EHL-Probe | Walz Elektronik GmbH | FFK | 2023-10-25 |
| 04260667540097 | EHL-Probe | Walz Elektronik GmbH | FFK | 2023-10-25 |
| 04260667540110 | EHL-Probe | Walz Elektronik GmbH | FFK | 2023-10-25 |
| 04260667540158 | EHL-Probe | Walz Elektronik GmbH | FFK | 2023-10-25 |
| 04260667540172 | EHL-Probe | Walz Elektronik GmbH | FFK | 2023-10-25 |
| 04260667540196 | EHL-Probe | Walz Elektronik GmbH | FFK | 2023-10-25 |
| 04260667540219 | EHL-Probe | Walz Elektronik GmbH | FFK | 2023-10-25 |
| 07290016498455 | Lithospec | MEDISPEC LTD. | FFK | 2023-06-08 |
| 07613353187101 | SWISS DolorClast | E.M.S. Electro Medical Systems S.A. | FFK | 2022-10-28 |
| 07613353001940 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2021-09-17 |
| 07613353001964 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2021-09-17 |
| 07613353062378 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2021-09-17 |
| 07613353062453 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2021-09-17 |
| 07613353062309 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2021-09-16 |
| 07613353062897 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2021-09-16 |
| 07613353064266 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2021-09-14 |
| 07613353204648 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2021-09-14 |
| 07613353151843 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | FFK | 2021-09-07 |