Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00810041334374
• Version / Model: Microscope Slide Non Adhesion
• Catalog Number: AA00008132E01MNZ10
• Company Name: NEW ERIE SCIENTIFIC LLC
• Labeler DUNS: 361605223
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 72
• Record Status: Published
• Publish Date: 2025-02-26
• Public Version: 1
• Public Version Date: 2025-03-06
• Public Version Status: New
• Public Device Record Key: 4f34198b-436d-4a11-888b-2c2c993ee9a4

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
KEW	Slides, Microscope	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57925	General specimen microscopy slide IVD, single-use	A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810041334374	GS1
Unit of Use	10810041334371	GS1