Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693227513
• Version / Model: Stainless Steel Base Molds
• Catalog Number: 6401016
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-08
• Public Version: 1
• Public Version Date: 2024-10-16
• Public Version Status: New
• Public Device Record Key: 8ccb86b2-0b80-4e31-9417-dfefbf2153a3

Device Description

Stainless-steel base molds are made of high-quality, durable stainless-steel fitting most cassettes with superior thermal exchange and round corners. Stainless-steel base molds can be cleaned with xylene or a paraffin repellant for continued use. Stainless-steel base molds come in four different sizes to accommodate different tissue sizes.

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: Yes
• 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
KER	Container, Embedding	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63792	Tissue embedding mould IVD, reusable	A metal container of square or rectangular shape intended to be used to embed tissue specimens into an embedding medium (e.g., paraffin wax) to form a solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It is typically made of stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693227513	GS1