Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693217880
• Version / Model: Double Cytofunnel™, White
• Catalog Number: 1102547
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-25
• Public Version: 1
• Public Version Date: 2024-08-02
• Public Version Status: New
• Public Device Record Key: 1662078b-d356-4795-98d0-ff2db124cfd6

Device Description

Double Cytofunnel is a disposable sample chamber with two chambers and pre-attached white filter card. It allows samples to be deposited into two deposition areas on a single slide which each measure 6 mm. The funnel can accommodate sample volumes up to 0.5 ml (0.25ml per side). Caps are also included but not necessary for use. The stainless steel Cytoclip, available separately, are used to mount the Cytofunnel to the slide for use with the Cytospin™ Cytocentrifuge. Double Cytofunnels are single use only.

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
IFB	Cytocentrifuge	Pathology	864.3300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63732	Cytological centrifuge funnel IVD	A small, tapered receptacle designed to be fitted into a cytological centrifuge/sample concentrator, and intended to contain and help concentrate clinical specimen suspension cells into thin-layer preparations by depositing them directly onto a microscope slide during centrifugation for subsequent examination. It is in the form of a conical-shaped plastic receptacle; some types have a slot for inserting a microscope slide. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693217880	GS1