Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- SHEATH RESECTOSCOPE 11.5FR color code yellow, SL 105 mm, oval, slanted distal end, compatible with attachment 8677.254, working element 8677.224 and telescopes Ø 2.7 mm 0°, with irrigation stopcock, quick-lock, reusable FDA UDI
- Model / Reference
- 86770145 FDA UDI
- Description
- SHEATH RESECTOSCOPE 11.5FR color code yellow, SL 105 mm, oval, slanted distal end, compatible with attachment 8677.254, working element 8677.224 and telescopes Ø 2.7 mm 0°, with irrigation stopcock, quick-lock, reusable FDA UDI
Identifiers
- Catalog Number
- 8677.0145 FDA UDI
- Primary DI / UDI-DI
- 04055207028216 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
- 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 — 3.83333333333 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 d5572998-59fc-4e9b-babc-c44c38706aa3 37 fields · synced Jun 1, 2026