Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Rigid optical ureterorenoscope FDA UDI
- Device Name
- URETERORENOSCOPE 12° 8/9,8FR WL 330MM semi-rigid, with straight ocular lens, working channel 1: 1x5FR, TL 472mm, fiber image carrier, reusable FDA UDI
- Model / Reference
- 8703517 FDA UDI
- Description
- URETERORENOSCOPE 12° 8/9,8FR WL 330MM semi-rigid, with straight ocular lens, working channel 1: 1x5FR, TL 472mm, fiber image carrier, reusable FDA UDI
Identifiers
- Catalog Number
- 8703,517 FDA UDI
- Primary DI / UDI-DI
- 04055207064160 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
- Length — 330 Millimeter FDA UDIAngle — 12 degree 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.
- 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
- 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 bc93e816-9d11-4351-bc8d-e423b0beb2c2 36 fields · synced May 30, 2026