SHARK/S-LINE

Basic Information

• Brand Name: SHARK/S-LINE
• Primary DI: 04055207018033
• Version / Model: 8623022
• Catalog Number: 8623022
• 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: 7
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 2ce95b15-bb16-483a-afa1-0e66e75becfa
• Distribution End Date: 2024-01-01

Device Description

COAG ELECTRODE BIPO 22-26FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, continuous irrigation, 22/24/26, Fr, electrode shape: cylinder, wire Ø 1.2mm, fork color blue, stem color yellow, PACK=1 PC, for Shark and S-Line Resectoscopes, 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
32684	Endoscopic electrosurgical handpiece/electrode, bipolar, reusable	An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open 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, rigid probe with controls). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207018033	GS1

Customer Contacts

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