E-LINE

Basic Information

• Brand Name: E-LINE
• Primary DI: 04055207010006
• Version / Model: 841104
• Catalog Number: 8411.04
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: c55c1650-ac8d-4712-aea0-1eb0fe88ef68
• Distribution End Date: 2024-01-01

Device Description

CUTTING ELECTRODE MONO 24FR 0° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent/continuous irrigation, 24/26/27 Fr, loop: round, wire Ø 0.4 mm, fork color green, stem color blue, PACK = 1 PC, for E-Line resectoscope, unsterile, reusable

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FAS	ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33596	Endoscopic electrosurgical handpiece/electrode, monopolar, reusable	An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207010006	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Angle	0	degree
Outer Diameter	8	Millimeter