ORBEYE SURGICAL MICROSCOPE

Basic Information

• Brand Name: ORBEYE SURGICAL MICROSCOPE
• Primary DI: 04953170395871
• Version / Model: OME-V200
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-21
• Public Version: 4
• Public Version Date: 2022-09-02
• Public Version Status: Update
• Public Device Record Key: bd508686-ab46-4af7-beeb-810d96b0e86f

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
EPT	MICROSCOPE, SURGICAL	General, Plastic Surgery	878.4700	1
IZI	System, X-Ray, Angiographic	Radiology	892.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35191	General-purpose surgical microscope	A general-purpose, surgical, light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures, e.g., nerves or vessels in the performance of delicate surgical procedures which require high magnification by transmitted light. An operating microscope will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170395871	GS1

Customer Contacts

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