Tissue-Tek Prisma®

Basic Information

• Brand Name: Tissue-Tek Prisma®
• Primary DI: 00615233011008
• Version / Model: 4900
• 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: 2024-10-11
• Public Version: 1
• Public Version Date: 2024-10-21
• Public Version Status: New
• Public Device Record Key: 22601b51-499f-4506-8017-9bafdb8f62c2

Device Description

H&E Stain Kit #2

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: 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
57764	Non-buffered formalin IVD	A non-buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens. Some formulations may contain additional components such as zinc, alcohol, and/or eosin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233011008	GS1

Customer Contacts

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