EVIS EXERA III DUODENOVIDEOSCOPE

Basic Information

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Primary DI: 04953170405563
• Version / Model: OLYMPUS TJF-Q190V
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-27
• Public Version: 5
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: b502ea76-d01f-4b89-a01c-0d5790e13ef4

Device Description

EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Ethylene Oxide", "High-level Disinfectant"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDT	Duodenoscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2
NWB	Endoscope, accessories, narrow band spectrum	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36112	Flexible video duodenoscope, reusable	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). It is inserted into the body through the mouth during duodenoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This device is commonly used to examine structures and mucous membranes of the duodenum for conditions like ulcers, polyps, and cancer. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170405563	GS1

Customer Contacts

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