Tissue-Tek® Quick-Ray™

Basic Information

• Brand Name: Tissue-Tek® Quick-Ray™
• Primary DI: 00615233081735
• Version / Model: 8010
• Catalog Number: 8010
• 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: 2020-03-17
• Public Version: 1
• Public Version Date: 2020-03-25
• Public Version Status: New
• Public Device Record Key: 6c04edc8-b44d-4b42-81e2-635a0552e153

Device Description

Tissue Microarray System

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KER	CONTAINER, EMBEDDING	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44663	Tissue microarray kit	A collection of equipment (e.g., moulds and instruments for tissue sampling and transfer) used to create a fixed array of tissue samples, usually for the parallel histopathological or immunohistochemical analysis of different tissues. The tissue samples are typically embedded in rows and columns of holes in a paraffin wax block formed by a mould.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233081735	GS1

Customer Contacts

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