Tissue-Tek® SmartWrite®

Basic Information

• Brand Name: Tissue-Tek® SmartWrite®
• Primary DI: 10615233082463
• Version / Model: 9031
• Catalog Number: 9031
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2020-02-16
• Public Version: 1
• Public Version Date: 2020-02-24
• Public Version Status: New
• Public Device Record Key: 888f81ff-6359-43e1-a19f-d38e2380070e

Device Description

Slide Print Cartridge Color; 6/case

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
LXG	EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62926	Microscope slide labelling cartridge IVD	A device designed to be inserted into an automated microscope slide processing instrument (e.g., printer, stainer, or maker) to label a microscope slide for specimen identification prior to blood smearing. It is a casing, similar to a paper printer cartridge, with a printer ribbon that makes thermal contact with the slide, with heat and printed data from the processing instrument, to transfer information to the slide.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10615233082463	GS1
Unit of Use	00615233082466	GS1

Customer Contacts

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