ThinPrep Imaging System

Basic Information

• Brand Name: ThinPrep Imaging System
• Primary DI: 25420045501093
• Version / Model: ThinPrep® Imaging System Microscope Slides, 100pk
• Catalog Number: ASY-07317
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2014-09-11
• Public Version: 6
• Public Version Date: 2024-04-08
• Public Version Status: Update
• Public Device Record Key: ca8077f1-eecc-48de-bcb1-b650adecbcd9

Device Description

Glass slides or use with ThinPrep® processors and ThinPrep® Imaging Systems for gynecological 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
MKQ	Processor, cervical cytology slide, automated	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
57951	Cervical cytology microscopy slide IVD	A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of a cervical cytology smear for analysis and/or other investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	25420045501093	GS1
Unit of Use	15420045501096	GS1
Package	35420045501090	GS1	BOX	500	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P950039	028