Tissue-Tek® SmartWrite®

Basic Information

• Brand Name: Tissue-Tek® SmartWrite®
• Primary DI: 00615233000262
• Version / Model: 9052
• Catalog Number: 9052
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-02-06
• Public Version: 1
• Public Version Date: 2020-02-14
• Public Version Status: New
• Public Device Record Key: b2a963c2-6719-49e3-9c5f-e92b6ce659db

Device Description

Pink Frosted Slides - Charged

Device Characteristics

• Single Use: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KEW	SLIDES, MICROSCOPE	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57925	General specimen microscopy slide IVD, single-use	A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233000262	GS1
Unit of Use	00615233000255	GS1

Customer Contacts

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