Tissue-Tek® SmartWrite®

Basic Information

• Brand Name: Tissue-Tek® SmartWrite®
• Primary DI: 00615233082411
• Version / Model: 9024
• Catalog Number: 9024
• 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: 2020-02-16
• Public Version: 2
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 694ed3fd-095f-4eef-948e-973c4f7f9eeb

Device Description

2D Barcode Scanner and Stand

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: Yes
• Has Lot/Batch Number: No
• 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
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
62002	Laboratory specimen/material barcode label	A label (e.g., a card or insert) featuring a barcode intended to facilitate clear and easy identification of a laboratory specimen and/or material (e.g., a clinical specimen or assay reagent/buffer in a container). It is electronically readable using a computerized reader or scanner, either on-board or connected to an instrument or analyser. This is a reusable device.	No	Active
61297	Barcode reader mount	A device intended to hold and secure a barcode reader in a position to facilitate its use when required. It is typically made of plastic and affixed to a wall or laboratory instrument.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233082411	GS1

Customer Contacts

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