Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693203845
• Version / Model: ParaPel
• Catalog Number: 2300
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-30
• Public Version: 1
• Public Version Date: 2024-08-07
• Public Version Status: New
• Public Device Record Key: e91721e1-525f-47d9-9693-52bf1cd2bc12

Device Description

ParaPel is designed to be used at full strength and does not require any additives. It is used as a paraffin repellent for countertops, microtomes and microtome accessories.

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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64424	Paraffin anti-adhesion agent IVD	A fluid substance (e.g., in a spray container) intended to be applied to the surface of laboratory working fixtures and equipment (e.g., countertop, microtome) to prevent the adherence of paraffin wax, or applied to the surface of tissue embedding moulds prior to the embedding procedure to facilitate release of the paraffin block, typically during pathology specimen preparation. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693203845	GS1