FDA UDI
In Commercial Distribution
🇺🇸 United States
Extracorporeal Shock Wave Lithotripter
DI: 06975438931018
·
Model: CS-2012A-3
·
Suzhou Xixin Medical Instruments Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Extracorporeal Shock Wave Lithotripter
- Primary DI
- 06975438931018
- Version / Model
- CS-2012A-3
- Company Name
- Suzhou Xixin Medical Instruments Co., Ltd.
- Labeler DUNS
- 527113190
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-25
- Public Version
- 1
- Public Version Date
- 2024-01-02
- Public Version Status
- New
- Public Device Record Key
- 082c2134-e305-4cef-9150-1647c4b76603
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | Gastroenterology, Urology | 876.5990 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18415 | Electromechanical lithotripsy system, extracorporeal | An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by an electromechanical generator. This generator contains a coil attached to a thin metallic membrane; a magnetic field is produced by an electric current conducted through the coil, and shock waves are generated when the metallic membrane is repelled by the magnetic field. The system also includes a treatment table, an imaging system, and an operator's console. This [extracorporeal shock wave lithotripsy (ESWL)] system is used to disintegrate stones located in the kidneys, urinary tract, gallbladder, or bile/pancreatic ducts. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06975438931018 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131817 | 000 |