Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- OUTER SHEATH RESECTOSCOPE 24.5FR color code green, SL 191 mm, round, non-rotatable, distal end straight, continuous irrigation, compatible with inner sheath 8655.344, and telescopes Ø 4 mm, 30°, with irrigation stopcock, E-Line quick connection, reusable FDA UDI
- Model / Reference
- 8655334 FDA UDI
- Description
- OUTER SHEATH RESECTOSCOPE 24.5FR color code green, SL 191 mm, round, non-rotatable, distal end straight, continuous irrigation, compatible with inner sheath 8655.344, and telescopes Ø 4 mm, 30°, with irrigation stopcock, E-Line quick connection, reusable FDA UDI
Identifiers
- Catalog Number
- 8655.334 FDA UDI
- Primary DI / UDI-DI
- 04055207018972 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 — 8.16666666666 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
Similar devices
Also classified as Endoscope sheath, reusable.
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- B.I.O.H. — Karl Storz GmbH & Co. KG · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- SpineTIP — Karl Storz GmbH & Co. KG · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Richard Wolf GmbH
Sources (1)
- FDA UDI aba79cb8-aad9-4a58-b6e1-8d43e8b20a88 37 fields · synced May 31, 2026