Identity
- Trade Name
- X-Filter basket FDA UDI
- Generic Name
- Ureteropelvic stone filtering catheter FDA UDI
- Device Name
- Anti Migration Device FDA UDI
- Model / Reference
- ROXE363609ST FDA UDI
- Description
- Anti Migration Device FDA UDI
Identifiers
- Catalog Number
- XF36150 FDA UDI
- Primary DI / UDI-DI
- 03700512968597 FDA UDI
- FDA Product Code
- OCY FDA UDIFFL FDA UDI
- GMDN Term
- Ureteropelvic stone filtering catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI876.4680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ureteropelvic stone filtering catheter
X-Filter basket by Promepla — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Manufacturer
- Promepla
Sources (1)
- FDA UDI 5acda16e-e106-4245-ac75-624a2385e8a8 34 fields · synced May 30, 2026