E-LINE

Basic Information

• Brand Name: E-LINE
• Primary DI: 04055207018286
• Version / Model: 8650204
• Catalog Number: 8650.204
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 8
• Public Version Date: 2024-11-21
• Public Version Status: Update
• Public Device Record Key: 07a3af29-7ea5-4707-8d5d-7d135eb30b8e

Device Description

WORKING INSERT FOR CYSTOSCOPE 0/30/70 with Albarran-lever, compatible with sheaths 86500245, 86500345, 86500445, 86500545, and telescopes Ø 4mm, with 2 introduction ports, bayonet-cap, 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
FBO	CYSTOURETHROSCOPE	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37085	Rigid endoscope working guide	An endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207018286	GS1

Customer Contacts

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