Tissue-Tek Prisma®

Basic Information

• Brand Name: Tissue-Tek Prisma®
• Primary DI: 00615233000040
• Version / Model: 6190
• Catalog Number: 6190
• 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: 2019-12-15
• Public Version: 1
• Public Version Date: 2019-12-23
• Public Version Status: New
• Public Device Record Key: f9231d01-a77c-4c3b-a026-020bdd77a85b

Device Description

H&E Stain Kit #1

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HZT	REAGENT, SCHIFF	Hematology	864.1850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42704	Haematoxylin and eosin (H&E) stain control IVD, kit	A prepared slide and/or other associated material used to verify the performance of a haematoxylin and eosin (H&E) stain/staining kit which is intended to be used for the demonstration of cell and tissue morphology in biological/clinical specimens.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233000040	GS1

Customer Contacts

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