Identity
- Trade Name
- Electrohydraulic Lithotriptor FDA UDI
- Generic Name
- Electrohydraulic lithotripsy system FDA UDI
- Model / Reference
- TCS-B3-II FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973204210763 FDA UDI
- 510(k) Number
- K242888 FDA UDI
- FDA Product Code
- FFK FDA UDI
- GMDN Term
- Electrohydraulic lithotripsy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4480 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrohydraulic lithotripsy system
Electrohydraulic Lithotriptor by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 3cb351f5-7da9-4f7e-8dc5-b485e4333d01 33 fields · synced Jun 6, 2026