Tissue-Tek® Accu-Edge®

Basic Information

• Brand Name: Tissue-Tek® Accu-Edge®
• Primary DI: 00615233012661
• Version / Model: 0159
• Catalog Number: 0159
• 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: 2020-03-31
• Public Version: 1
• Public Version Date: 2020-04-08
• Public Version Status: New
• Public Device Record Key: 37cc99ce-2294-4ba3-b79e-c117a627ae8c

Device Description

Dissecting Board

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16859	Dissection board	A flat, stiff device on which an object (a human or animal body or body part) is placed for support during dissection procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233012661	GS1

Customer Contacts

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