SHARK

Basic Information

• Brand Name: SHARK
• Primary DI: 04055207019566
• Version / Model: 8673124
• Catalog Number: 8673124
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2021-04-27
• Public Version Status: Update
• Public Device Record Key: 2c6f941a-f789-4d41-bb45-87162b44f152

Device Description

VIEWING OBTURATOR RESECTOSCOPE 24FR color code yellow, WL 232mm, rounded distal end, compatible with Shark sheaths 8675324, 8676324, 8676424, and telescopes Ø 4mm, 0°/12°/30°, 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
FJL	RESECTOSCOPE	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35692	Rigid endoscope obturator	An endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207019566	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	8	Millimeter