Tissue-Tek Prisma® 6168

GUDID 00615233080585

Tissue-Tek Prisma® Link Between Tissue-Tek Prisma® and Tissue-Tek® Glas™ g2

SAKURA FINETEK U.S.A., INC.

Microscope slide coverslipper IVD

• Primary Device ID: 00615233080585
• NIH Device Record Key: 3634c261-bce3-4102-9854-0454876416bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue-Tek Prisma®
• Version Model Number: 6168
• Catalog Number: 6168
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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	00615233080585 [Primary]

FDA Product Code

• KIO: SLIDE STAINER, IMMERSION TYPE

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: 2020-03-25
• Device Publish Date: 2020-03-17

On-Brand Devices [Tissue-Tek Prisma®]

• 00615233000040: H&E Stain Kit #1
• 00615233080585: Tissue-Tek Prisma® Link Between Tissue-Tek Prisma® and Tissue-Tek® Glas™ g2
• 00615233080332: Link System Kit for Tissue-Tek Film® Coverslipper
• 00615233011008: H&E Stain Kit #2