VisionTek®

Basic Information

• Brand Name: VisionTek®
• Primary DI: 00615233082367
• Version / Model: 9011
• Catalog Number: 9011
• 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: 2020-03-17
• Public Version: 1
• Public Version Date: 2020-03-25
• Public Version Status: New
• Public Device Record Key: b77dca77-841f-433d-8166-7a20b58242b0

Device Description

Slide Carrier

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
42833	Microscope slide holder, preparation/staining	A holder used in the laboratory to hold microscope slides in an upright position during the preparation or staining procedures. It is typically made of plastic materials, will sit sturdily upon a flat surface (e.g., a laboratory bench top or on a shelf) and has a series of spaced slots into which the slides are placed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233082367	GS1

Customer Contacts

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