Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- INNER SHEATH RESECTOSCOPE 26FR color code black, SL 204mm, round, rotatable, straight distal end, ceramic, continuous irrigation, compatible with outer sheath 8655393, and telescopes Ø 4mm, 0°, with irrigation stopcock, quick-lock, reusable FDA UDI
- Model / Reference
- 8655394 FDA UDI
- Description
- INNER SHEATH RESECTOSCOPE 26FR color code black, SL 204mm, round, rotatable, straight distal end, ceramic, continuous irrigation, compatible with outer sheath 8655393, and telescopes Ø 4mm, 0°, with irrigation stopcock, quick-lock, reusable FDA UDI
Identifiers
- Catalog Number
- 8655.394 FDA UDI
- Primary DI / UDI-DI
- 04055207059722 FDA UDI
- FDA Product Code
- FDC FDA UDI
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
E-Line by Richard Wolf GmbH — 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
- Richard Wolf GmbH
Sources (1)
- FDA UDI e123b74a-88ac-4516-97bc-936028bc5bab 36 fields · synced May 31, 2026