Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693105279
• Version / Model: Histogel™
• Catalog Number: HG-4000-012
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-04
• Public Version: 1
• Public Version Date: 2024-08-12
• Public Version Status: New
• Public Device Record Key: 868e7f54-9b9f-495e-bcc4-3ed279983e61

Device Description

HistoGel is a gel-based embedding and processing medium that encapsulates and retains the entire specimen during histological processing. HistoGel should be a consistently translucent gelatin material with a slightly pink color.

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
LEA	Preservative, Cytological	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62706	Agar powder IVD	A gelling agent intended to be used to create a solid culture medium for the isolation of single microbial colonies. It is presented as a powdered substance which is added to a heated liquid preparation which cools to form a solid medium.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693105279	GS1