Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 05051663517904
• Version / Model: Cool-Cut with STD
• Catalog Number: 771120
• Company Name: SHANDON DIAGNOSTICS LIMITED
• Labeler DUNS: 219103512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-14
• Public Version: 1
• Public Version Date: 2024-02-22
• Public Version Status: New
• Public Device Record Key: 79b3b013-7777-4000-8f7f-42f0b787175a

Device Description

Rotary Microtome - Accessory

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IDO	Microtome, Rotary	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15158	Rotary microtome IVD	A precision cutting instrument intended to be used to cut tissue sections, fixed in paraffin wax, into thin slices for subsequent in vitro diagnostic analysis. The device has a vertically-fixed knife which cuts through the paraffin block vertically, and a flywheel mechanism which cuts sections with each turn.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051663517904	GS1