Accu-Edge®

Basic Information

• Brand Name: Accu-Edge®
• Primary DI: 24902470058195
• Version / Model: 4689
• Catalog Number: 4689
• 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: 2020-03-31
• Public Version: 3
• Public Version Date: 2020-08-20
• Public Version Status: Update
• Public Device Record Key: be3a117b-c46c-4eb9-9e35-b90bbe24409c

Device Description

Low 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
42439	Microtome blade IVD, reusable	A flat, wedge-shaped, sharp blade intended to be mounted into a microtome to cut micro-thin slices of tissue that may either be frozen or fixed, and usually impregnated, with paraffin wax. The resulting sections are mounted onto glass slides for staining and then viewing with a microscope. The cutting edge will typically need to be sharpened at intervals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	24902470058195	GS1
Unit of Use	14902470058198	GS1

Customer Contacts

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