Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693591508
• Version / Model: HP35N Ultra Microtome Blade
• Catalog Number: 3151735
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-01
• Public Version: 1
• Public Version Date: 2024-08-09
• Public Version Status: New
• Public Device Record Key: a5f8a3ce-25b8-4524-9916-5436b5b461c1

Device Description

The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Expiration Date: Yes
• 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
Primary	00673693591508	GS1