ThinPrep

Basic Information

• Brand Name: ThinPrep
• Primary DI: 25420045510064
• Version / Model: ThinPrep® UroCyte® Filters, 100pk
• Catalog Number: 70472-001
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-09-10
• Public Version: 3
• Public Version Date: 2024-11-07
• Public Version Status: Update
• Public Device Record Key: 73939537-e0a3-4ee2-b3d6-0a74f593d851

Device Description

For use with a ThinPrep® processor for urine specimens.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
KET	FILTERS, CELL COLLECTION, TISSUE PROCESSING	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15110	Microscope slide maker IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used to prepare, transfer and/or fix blood, tissue, cytology specimens, or other clinical specimens onto microscope examination slides so they are suitable for subsequent staining and/or microscopic analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	25420045510064	GS1
Unit of Use	15420045510067	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]