REFERENCE PLATE

Basic Information

• Brand Name: REFERENCE PLATE
• Primary DI: 04953170305672
• Version / Model: MAJ-1860
• 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: 8
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: e14ee8a3-df5c-451f-abd9-77027373759a

Device Description

MAJ-1860 ScopeGuide Reference Plate

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: 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

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
64680	Electromagnetic endoscope tracking system reference transmitter, external, body-surface	An external component of an electromagnetic (EM) endoscope tracking system designed to emit EM pulses for spatial referencing of an appropriate EM pulse-transmitting endoscope in situ. It is intended to be attached to, or held next to, the patient; the system sensor (not included) simultaneously receives signals from both the endoscope and the reference transmitter for spatial referencing. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170305672	GS1

Customer Contacts

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