ThinPrep Imaging System

Basic Information

• Brand Name: ThinPrep Imaging System
• Primary DI: 15420045500907
• Version / Model: ThinPrep Imaging System Review Scope
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-02
• Public Version: 4
• Public Version Date: 2020-11-16
• Public Version Status: Update
• Public Device Record Key: 967b2c1b-0dc6-40ba-bafc-e3f42ad724b1

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: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
MNM	READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
35484	Basic light microscope	A magnification instrument designed with a standard microscope configuration [the object viewed through an ocular(s) from above] used to magnify and study specimens and small objects by transmitted visible light. It is widely used in laboratories and for research and in healthcare facilities where there is a need for such magnification. The device consists of a stand that supports the main components, an ocular body in which the eyepieces are mounted, a nosepiece to support the objectives, a specimen stage, a condenser to focus the light on the specimen, and a source of light [e.g., tungsten (W), halogen] and light port.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045500907	GS1

Premarket Submissions

Submission Number	Supplement Number
P020002	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 16 – 32 Degrees Celsius