Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 05051663517676
• Version / Model: Wash bottle
• Catalog Number: AP18730
• 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: fe411e0a-3d9d-4416-b8c4-7cab7f8e6a85

Device Description

Slide Basket Transfer System - 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: No
• Has Lot/Batch Number: Yes
• 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
KIM	Device For Sealing Microsections	Pathology	864.3400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58025	Laboratory container/microscope slide robotic transfer system IVD	An assembly of electrically-powered robotic devices, a stand-alone device, or a belt conveyor intended to be used for the automated or semi-automated transfer of assay containers (e.g., test tubes, microplates), microscope slides/slide carriers, or racks between processing stations. The system may interface with individual instruments/analysers and other equipment, transporting assay containers between stations which may include specimen pipetting, reagent dispensing, incubation, microplate washing, agitation, barcode reading and/or optical reading.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051663517676	GS1