OBCU REMOTE CONTROLLER

Basic Information

• Brand Name: OBCU REMOTE CONTROLLER
• Primary DI: 04953170239564
• Version / Model: MAJ-1726
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: dc2e4c4c-c3ff-4483-80db-299e121c634f

Device Description

MAJ-1726 OBCU REMOTE CONTROLLER

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDA	Enteroscope and accessories	Gastroenterology, Urology	876.1500	2
FED	endoscopic access overtube, gastroenterology-urology	Gastroenterology, Urology	876.1500	2
NWB	Endoscope, accessories, narrow band spectrum	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61583	Endoscopic device remote control	A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an endoscopic device (e.g., endoscope video camera) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170239564	GS1

Customer Contacts

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