Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- EVAP-ELECTRODE MONO 22FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent/continuous irrigation, 22/24.5/25.5 Fr, wing (flat loop profile), fork color blue, stem color blue, PACK = 1 PC, for E-Line resectoscope, unsterile, reusable FDA UDI
- Model / Reference
- 8422151 FDA UDI
- Description
- EVAP-ELECTRODE MONO 22FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent/continuous irrigation, 22/24.5/25.5 Fr, wing (flat loop profile), fork color blue, stem color blue, PACK = 1 PC, for E-Line resectoscope, unsterile, reusable FDA UDI
Identifiers
- Catalog Number
- 8422.151 FDA UDI
- Primary DI / UDI-DI
- 04055207017111 FDA UDI
- FDA Product Code
- KNF FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4160 FDA UDI
- Commercial Distribution
- Not 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 — 7.33333333333 Millimeter FDA UDI
E-Line by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 23c3484c-d40c-4891-89da-436c8b82c4fb 37 fields · synced Jun 8, 2026