Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693083775
• Version / Model: Disposable Base Molds
• Catalog Number: 58952
• 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: 4875692b-51fb-4f1c-9c8f-e866f428d9df

Device Description

Disposable Base Molds are designed for use with all standard size tissue cassettes and embedding rings. They are molded from rigid plastic and the block design provides greater base support and smaller cutting surfaces. Cleaning associated with metal molds is not required and the transparency facilitates tissue orientation. Disposable base molds come in four different sizes to accommodate different tissue sizes.

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
KER	Container, Embedding	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63791	Tissue embedding mould IVD, single-use	A plastic 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 synthetic polymer materials (e.g., plastic) This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693083775	GS1