AccuThrive®

Basic Information

• Brand Name: AccuThrive®
• Primary DI: 00843382104009
• Version / Model: Microtome Blade
• Catalog Number: AVBL-2007-0000
• Company Name: AccuTec, Inc.
• Labeler DUNS: 079966794
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-17
• Public Version: 1
• Public Version Date: 2024-12-25
• Public Version Status: New
• Public Device Record Key: e79755af-0cb2-4261-81b3-6020e25d762d

Device Description

AccuThrive Agility Microtome Blade Low Profile SS Microcoat 500BL/CA (50BL/DISP 10 DISP/CA)

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
IDL	Microtome, Accessories	Pathology	864.3010	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
Package	10843382104006	GS1	Case	10	In Commercial Distribution
Primary	00843382104009	GS1

Customer Contacts

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