Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 05051663009423
• Version / Model: CYTOSPIN 4
• Company Name: SHANDON DIAGNOSTICS LIMITED
• Labeler DUNS: 219103512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-10
• Public Version: 5
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 294c7b09-111a-428d-8368-3a6d92440fab

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
IFB	Cytocentrifuge	Pathology	864.3300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35881	Cytological centrifuge IVD	An electrically-powered device intended to be used in a clinical laboratory setting to separate the cellular components of suspensions in a clinical specimen through centrifugal force for subsequent cytological analysis. It is typically a compact unit with an electric motor, a vertical shaft, and a special horizontal rotor attached that enables cells to be separated from a liquid suspension and deposited directly onto a microscope slide for microscopic examination.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051663009423	GS1