Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- SHEATH FOR CYSTOSCOPE 16FR color code yellow, SL 231 mm, oval, slanted distal end, capacity for instruments up to 5 Fr, compatible with attachments 8650.254, 8650.264, 8650.284 and telescopes Ø 4 mm, with 2 flushing ports, quick-lock, reusable FDA UDI
- Model / Reference
- 86500145 FDA UDI
- Description
- SHEATH FOR CYSTOSCOPE 16FR color code yellow, SL 231 mm, oval, slanted distal end, capacity for instruments up to 5 Fr, compatible with attachments 8650.254, 8650.264, 8650.284 and telescopes Ø 4 mm, with 2 flushing ports, quick-lock, reusable FDA UDI
Identifiers
- Catalog Number
- 8650.0145 FDA UDI
- Primary DI / UDI-DI
- 04055207027837 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
- 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 — 5.33333333333 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 ffb0afae-7e3e-4085-a16c-9a2bbe7f47e2 37 fields · synced Jun 1, 2026