Tissue-Tek Prisma® 6190

GUDID 00615233000040

H&E Stain Kit #1

SAKURA FINETEK U.S.A., INC.

Haematoxylin and eosin (H&E) stain control IVD, kit

• Primary Device ID: 00615233000040
• NIH Device Record Key: f9231d01-a77c-4c3b-a026-020bdd77a85b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue-Tek Prisma®
• Version Model Number: 6190
• Catalog Number: 6190
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00615233000040 [Primary]

FDA Product Code

• HZT: REAGENT, SCHIFF

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: 2019-12-23
• Device Publish Date: 2019-12-15

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