EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

Basic Information

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Primary DI: 04953170339752
• Version / Model: OLYMPUS GIF TYPE 2TH180
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 5
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: 9fcc4379-d845-4db0-a11f-a02c31cbd3ab
• Distribution End Date: 2021-08-06

Device Description

GIF-2TH180 THERAPEUTIC 2-CHANNEL HDTV GA

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: ["High-level Disinfectant", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDS	Gastroscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2
FDF	Colonoscope 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
38805	Flexible video gastroduodenoscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. 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. It can be end-viewing (looking forward) or side-viewing (looking to one side) and is used for the cannulation of the pancreas and bile duct. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170339752	GS1

Customer Contacts

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