n.a.
- Primary DI
- 04048551079546
- Brand
- n.a.
- Company
- Karl Storz GmbH & Co. KG
- Model
- 27080TA
- Device description
- Test Probe, 7 Fr.
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| FFK | Lithotriptor, electro-hydraulic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04048551079546 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04048551079546 | 04048551079546 | 4048551079546 |
GMDN Terms
| Term | Definition |
|---|---|
| Urethral bougie, reusable | A rod-like manual surgical instrument designed to explore the urethra and/or to dilate a urethral and/or urinary meatus stenosis. It is designed with a semi-rigid tapered shaft that terminates at the distal end in a small bulbous tip (an olive) and it typically has a handle at the proximal end. It may be hollow to enable passage of other slender devices. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 315731430
- 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
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04048551232378 | n.a. | 27033U | 27033U | 2025-08-11 |
| 04048551232781 | n.a. | 27047B | 27047B | 2025-08-11 |
| 04048551418123 | n.a. | TC304US | TC304US | 2025-08-11 |
| 04048551210567 | n.a. | 8574GY | 8574GY | 2018-09-04 |
| 04048551210574 | n.a. | 8574GZ | 8574GZ | 2018-09-04 |
| 04048551211281 | n.a. | 8587K | 8587K | 2018-09-04 |
| 04048551211427 | n.a. | 8588K | 8588K | 2018-09-04 |
| 04048551211694 | n.a. | 8590KC | 8590KC | 2018-09-04 |
| 04048551425749 | n.a. | 40410LH | 40410LH | 2025-07-10 |
| 04048551425756 | n.a. | 40410LS | 40410LS | 2025-07-10 |
| 04048551425763 | n.a. | 40410LG | 40410LG | 2025-07-10 |
| 04048551425770 | n.a. | 40410LC | 40410LC | 2025-07-10 |
| 04048551425787 | n.a. | 40410LL | 40410LL | 2025-07-10 |
| 04048551425794 | n.a. | 40410LF | 40410LF | 2025-07-10 |
| 04048551425800 | n.a. | 40410LR | 40410LR | 2025-07-10 |
| 04048438008867 | NA | 051111-10 | 051111-10 | 2025-03-28 |
| 04048438008911 | NA | 051110-10 | 051110-10 | 2025-03-28 |
| 04048551010242 | NA | 497HCS | 497HCS | 2025-03-28 |
| 04048551012468 | NA | 11900RA | 11900RA | 2025-03-28 |
| 04048551061343 | NA | 20090331 | 20090331 | 2025-03-28 |
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 |
| 04260667540134 | 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 |