Accu-Edge®

Basic Information

• Brand Name: Accu-Edge®
• Primary DI: 24902470058188
• Version / Model: 4685
• Catalog Number: 4685
• 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: 2020-03-17
• Public Version: 2
• Public Version Date: 2020-08-20
• Public Version Status: Update
• Public Device Record Key: cf0be792-bbee-42ee-bd90-301620dadf74

Device Description

High Profile Microtome Blades

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
GES	BLADE, SCALPEL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42440	Microtome blade IVD, single-use	A flat, wedge-shaped, sharp blade intended to be mounted into a microtome to cut micro-thin slices of tissue that has been fixed, and usually impregnated, with paraffin wax. The resulting sections are mounted onto slides for staining and then viewing with a microscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	24902470058188	GS1
Unit of Use	14902470058181	GS1

Customer Contacts

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