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Working elements for urethrotomes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8670.911Model 10000201325
Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Urethrotome FDA UDI
- Device Name
- Working elements for urethrotomes EUDAMEDWORKING ELEMENT URETHRO PASSIVE 0° holder for stricture scalpels, closed, compatible with sheath 8670011, and telescopes Ø 3.3mm, 0°, bayonet-cap, reusable FDA UDI
- Model / Reference
- 10000201325 EUDAMED8670.911 EUDAMED8670911 FDA UDI
- Description
- WORKING ELEMENT URETHRO PASSIVE 0° holder for stricture scalpels, closed, compatible with sheath 8670011, and telescopes Ø 3.3mm, 0°, bayonet-cap, reusable FDA UDI
Identifiers
- Catalog Number
- 8670.911 FDA UDI
- Primary DI / UDI-DI
- 04055207019375 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018414P9 EUDAMED
- Direct Marketing DI
- 04055207019375 EUDAMED
- FDA Product Code
- EZO FDA UDI
- EMDN Code
- L06040501 ENDOSCOPIC SURGERY URETHROTOMES AND URETEROTOMES, REUSABLE EUDAMED
- GMDN Term
- Urethrotome FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4770 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Dimensions & Sizes
- Size
- Angle — 0 degree FDA UDI
Working elements for urethrotomes by Richard Wolf GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 405520727052019-0018414P9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED a839131a-7277-4ed9-8611-e03893ee3742 61 fields · synced Jul 9, 2026
- FDA UDI 6da5110b-8768-46d0-89ba-00e15918b84d 36 fields · synced May 30, 2026