Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693088947
• Version / Model: Cytoseal™ 60
• Catalog Number: 8310-16
• 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: 4464f68f-0212-4623-9a7f-4a85fcf54d41

Device Description

Cytoseal™ 60 is a toluene-based mounting medium formulated from acrylic resins and will not crack or discolor with age. The addition of antioxidants inhibits fading or yellowing of stained specimens. This is a low-viscosity medium that dries quickly and allows for rapid, even spreading which virtually eliminates air bubbles.

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	00673693088947	GS1