VisionTek® 9000

GUDID 00615233082268

Digital Microscope

SAKURA FINETEK U.S.A., INC.

Microscope slide digital imaging scanner IVD

• Primary Device ID: 00615233082268
• NIH Device Record Key: b4693ad9-0710-4a6b-a1e1-e3be4c4e2819
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VisionTek®
• Version Model Number: 9000
• Catalog Number: 9000
• Company DUNS: 179135769
• Company Name: SAKURA FINETEK U.S.A., INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(310)972-7800
• Email: TS@sakuraus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615233082268 [Primary]

FDA Product Code

• IBJ: LIGHT, MICROSCOPE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-28
• Device Publish Date: 2020-02-20

On-Brand Devices [VisionTek®]

• 00615233082268: Digital Microscope
• 00615233082367: Slide Carrier