Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- SHEATH FOR URETHROTOME 16.5FR SL 194mm, oval, non-rotatable, slanted distal end, stainless steel, continuous irrigation, compatible with telescopes Ø 3.3mm, 0°, with introduction port, quick-lock, reusable FDA UDI
- Model / Reference
- 8670011 FDA UDI
- Description
- SHEATH FOR URETHROTOME 16.5FR SL 194mm, oval, non-rotatable, slanted distal end, stainless steel, continuous irrigation, compatible with telescopes Ø 3.3mm, 0°, with introduction port, quick-lock, reusable FDA UDI
Identifiers
- Catalog Number
- 8670.011 FDA UDI
- Primary DI / UDI-DI
- 04055207019337 FDA UDI
- FDA Product Code
- EZO FDA UDI
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4770 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 — 5.5 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 7cd8f27e-8364-4e3b-b58e-c40465df09b4 36 fields · synced May 30, 2026