Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693237499
• Version / Model: Xylene Substitute
• Catalog Number: 9999122
• 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: 0f3fa2f0-d200-436d-8e03-c1812ed5972c

Device Description

Xylene Substitute Mountant was specially formulated for its compatibility with Epredia™ Xylene Substitute, but it will work very well in all routine mounting of specimens with xylene. Although compatible with Xylene Substitute, this mounting medium is not soluble in it. See the section on “Removing A Coverslip” on Instructions for 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
LEB	Mounting Media	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43550	Microscopy mounting medium IVD	A substance intended to be used to create a seal between a microscope slide, clinical specimen and/or coverslip, to preserve the specimen and/or the integrity of any dye(s) used for staining, and enhance image quality during microscopic examination.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693237499	GS1