Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00810041339041
• Version / Model: Cover Slips
• Catalog Number: BB02400550AC13MNZ0
• Company Name: NEW ERIE SCIENTIFIC LLC
• Labeler DUNS: 361605223
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2025-03-13
• Public Version: 1
• Public Version Date: 2025-03-21
• Public Version Status: New
• Public Device Record Key: 4cb9f2dd-440d-4071-93dc-88bd0a0051a6

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
KES	Coverslips, Microscope Slide	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15687	Microscope slide coverslip IVD	A thin piece of glass or a plastic sheath placed over a specimen on a microscope slide, to serve as a physical barrier to protect the specimen from mechanical forces and environmental exposure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810041339041	GS1
Unit of Use	10810041339048	GS1