Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- OUTER SHEATH RESECTOSCOPE 25.5FR color code green, SL 192, round, non-rotatable, slanted distal end, continuous irrigation, compatible with inner sheath 8655144, and telescopes Ø 4mm, 12°/30°, E-Line quick connection, reusable FDA UDI
- Model / Reference
- 8655134 FDA UDI
- Description
- OUTER SHEATH RESECTOSCOPE 25.5FR color code green, SL 192, round, non-rotatable, slanted distal end, continuous irrigation, compatible with inner sheath 8655144, and telescopes Ø 4mm, 12°/30°, E-Line quick connection, reusable FDA UDI
Identifiers
- Catalog Number
- 8655.134 FDA UDI
- Primary DI / UDI-DI
- 04055207018910 FDA UDI
- FDA Product Code
- FJL 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 8.5 Millimeter 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 16e5b1a2-bb37-48e2-8e9c-c69f71fd4012 37 fields · synced Jun 8, 2026