ThinPrep Pap Test

GUDID 25420045501109

Hologic, Inc.

Cervical cytology microscopy slide IVD

• Primary Device ID: 25420045501109
• NIH Device Record Key: 398dee87-cda2-4a45-991c-1a936743e328
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThinPrep Pap Test
• Version Model Number: ThinPrep Microscope Slides
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 100
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045501102 [Unit of Use]
GS1	25420045501109 [Primary]
GS1	35420045501106 [Package]; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950039
• Premarket Approval: P950039

FDA Product Code

• MKQ: Processor, cervical cytology slide, automated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-11

On-Brand Devices [ThinPrep Pap Test]

• 25420045501109: ThinPrep Microscope Slides
• 25420045501086: ThinPrep Pap Test Filters
• 15420045504011: ThinPrep Pap Test Physician Kit
• 15420045504004: ThinPrep Pap Test Physician Kit
• 15420045501072: ThinPrep Pap Test PreservCyt Solution
• 15420045514652: ThinPrep Pap Test PreservCyt Solution
• 15420045514683: ThinPrep Pap Test Filters