Identity
- Trade Name
- UROLIFT ® FDA UDI
- Generic Name
- Luminal device flushing tubing set, reusable FDA UDI
- Device Name
- Tube Connector Luer Lock with Stop Cock FDA UDI
- Model / Reference
- 42.0471a FDA UDI
- Description
- Tube Connector Luer Lock with Stop Cock FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250480106525 FDA UDI
- FDA Product Code
- HIH FDA UDIFAJ FDA UDI
- GMDN Term
- Luminal device flushing tubing set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 FDA UDI876.1500 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Luminal device flushing tubing set, reusable
Urolift ® by SCHÖLLY FIBEROPTIC GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SCHÖLLY FIBEROPTIC GmbH
Sources (2)
- FDA UDI b5d92e4c-f452-4adf-a8bb-2944bc1389de 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026