Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- SHEATH FOR CYSTOSCOPE 9.5FR color code yellow, SL 145 mm, round, slanted distal end, compatible with telescopes Ø 1.9 mm, with 2 flushing ports and 1 guide port, quick-lock, reusable FDA UDI
- Model / Reference
- 86860345 FDA UDI
- Description
- SHEATH FOR CYSTOSCOPE 9.5FR color code yellow, SL 145 mm, round, slanted distal end, compatible with telescopes Ø 1.9 mm, with 2 flushing ports and 1 guide port, quick-lock, reusable FDA UDI
Identifiers
- Catalog Number
- 8686.0345 FDA UDI
- Primary DI / UDI-DI
- 04055207028551 FDA UDI
- FDA Product Code
- FBO FDA UDI
- GMDN Term
- Endoscope sheath, reusable 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
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
- Outer Diameter — 3.16666666666 Millimeter FDA UDI
Category: Endoscope sheath, reusable
E-Line by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 164b05e8-35e5-4b3a-bfb0-04a9ba5cdd44 37 fields · synced Jun 1, 2026