Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693214254
• Version / Model: Embedding Rings Blue
• Catalog Number: 1000956
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-02
• Public Version: 1
• Public Version Date: 2024-08-12
• Public Version Status: New
• Public Device Record Key: ca0333ce-4919-4a33-987b-45c9c343e0f9

Device Description

The embedding rings are an alternative to a tissue cassette to securely hold the tissue sample for sectioning. They are made of high impact polystyrene. The ring fits well in microtome chuck adapters. Embedding rings are not used in processing.

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
63813	Tissue embedding mould holder IVD	A preformed plastic device intended to contain and hold a tissue embedding mould during an embedding procedure (e.g., in paraffin wax) to form a tissue solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It may also be referred to as an embedding ring and typically has a writing surface to facilitate specimen identification. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693214254	GS1