OLYMPUS

Basic Information

• Brand Name: OLYMPUS
• Primary DI: 04953170385032
• Version / Model: OEP-5
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-15
• Public Version: 1
• Public Version Date: 2019-07-23
• Public Version Status: New
• Public Device Record Key: 445a537a-c904-4eb7-8a74-0248dfa3f136

Device Description

COLOR VIDEO PRINTER OEP-5

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: Yes
• 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
KQM	CAMERA, SURGICAL AND ACCESSORIES	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17508	Video printer	A device designed for making printed (hard) copies of medical video images. These can be taken by digital cameras or image processing results of different imaging devices or systems [e.g., ultrasound (US), magnetic resonance imaging (MRI), computed tomography (CT) or radiographic images].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170385032	GS1

Customer Contacts

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