Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Rigid optical ureterorenoscope FDA UDI
- Device Name
- URETERORENOSCOPE 12° 8/9.8FR WL 430MM semi-rigid, with lateral ocular lens, working channel 1x5 (2x3)Fr, atraumatic distal tip, TL 599mm, fiber image carrier FDA UDI
- Model / Reference
- 8703524 FDA UDI
- Description
- URETERORENOSCOPE 12° 8/9.8FR WL 430MM semi-rigid, with lateral ocular lens, working channel 1x5 (2x3)Fr, atraumatic distal tip, TL 599mm, fiber image carrier FDA UDI
Identifiers
- Catalog Number
- 8703.524 FDA UDI
- Primary DI / UDI-DI
- 04055207020081 FDA UDI
- FDA Product Code
- FGB FDA UDI
- GMDN Term
- Rigid optical ureterorenoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Angle — 12 degree FDA UDILength — 430 Millimeter FDA UDI
Category: Rigid optical ureterorenoscope
E-Line by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical ureterorenoscope.
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- Ureterorenoscope — SOPRO-COMEG GmbH · Class II
- Ureterorenoscope — SOPRO-COMEG GmbH · Class II
- Ureterorenoscope — SOPRO-COMEG GmbH · Class II
- Ureterorenoscope — SOPRO-COMEG GmbH · Class II
- Ureterorenoscope — SOPRO-COMEG GmbH · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
- Ureterorenoscope — SOPRO-COMEG GmbH · Class II
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
- Richard Wolf GmbH
Sources (1)
- FDA UDI 3b5d1c1c-f0fc-441c-b001-74e36ec299d8 36 fields · synced May 30, 2026