Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693228657
• Version / Model: PapSpin™ Collection Fluid
• Catalog Number: 6768350
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-29
• Public Version: 1
• Public Version Date: 2024-08-06
• Public Version Status: New
• Public Device Record Key: b2c78228-c2f2-4039-aab9-bd5ce3afe826

Device Description

PapSpin™ Collection Fluid is used for the cytological fixation of gynecological samples. The collection fluid may be used independently or in conjunction with the EZ Megafunnels and Megafunnel cytoslides as found in the PapSpin™ Collection Fluid Kit.

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
LEA	Preservative, Cytological	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57743	Cytology fixative solution IVD	An alcohol-based solution intended to be used as a fixative for a cytology specimen obtained directly from a patient, or processing of a clinical specimen, for subsequent preservation, transportation and/or in vitro diagnostic analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693228657	GS1