VisionTek®

Basic Information

• Brand Name: VisionTek®
• Primary DI: 00615233082268
• Version / Model: 9000
• Catalog Number: 9000
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-20
• Public Version: 1
• Public Version Date: 2020-02-28
• Public Version Status: New
• Public Device Record Key: b4693ad9-0710-4a6b-a1e1-e3be4c4e2819

Device Description

Digital Microscope

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
IBJ	LIGHT, MICROSCOPE	Pathology	864.3600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62575	Microscope slide digital imaging scanner IVD	A mains electricity (AC-powered) device designed to be used in a histopathology laboratory to scan clinical specimens on microscope slides, at a microscopic level, to produce images in a digital format. Also known as a whole slide scanner or digital pathology slide scanning system, it is a bench-top unit with slide tray slots, high-resolution cameras, a user interface, and integrated software for image creation, viewing, and management to aid the pathologist to review and interpret slide images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233082268	GS1

Customer Contacts

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