DISTAL HOOD

Basic Information

• Brand Name: DISTAL HOOD
• Primary DI: 04953170314391
• Version / Model: DISTAL HOOD 11302 MAJ-1989
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 6
• Public Version Date: 2022-08-11
• Public Version Status: Update
• Public Device Record Key: a7d741e1-8c67-49e5-ba5b-cee9c6ff66a6
• Distribution End Date: 2022-08-10

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: Yes
• 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: ["High-level Disinfectant", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDS	Gastroscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65403	Endoscope observation cap, reusable	A short, light-penetrating tube designed to be placed onto the distal end of an endoscope (e.g., colonoscope) to facilitate observation by retaining a short distance between the endoscope tip and lumen wall or other structure of interest. It typically has a small hole to allow fluid drain from inside the cap and is available in a range of diameters to accommodate common endoscope diameters. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170314391	GS1
Unit of Use	84953170314397	GS1

Customer Contacts

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