Tissue-Tek Genie®

Basic Information

• Brand Name: Tissue-Tek Genie®
• Primary DI: 00615233002686
• Version / Model: 8874-G004
• Catalog Number: 8874-G004
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• 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: eca5258d-2a9b-417e-9eac-d7a2d5c2dd85

Device Description

Wash Buffer

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
PPM	General purpose reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57784	Immunohistochemistry wash buffer reagent IVD	A substance or reactant intended to be used to perform a specific washing function in an enzyme immunohistochemistry assay performed on a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233002686	GS1
Unit of Use	00615233000101	GS1

Customer Contacts

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