ThinPrep Imaging System

GUDID 25420045501093

Hologic, Inc.

Cervical cytology microscopy slide IVD

• Primary Device ID: 25420045501093
• NIH Device Record Key: ca8077f1-eecc-48de-bcb1-b650adecbcd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThinPrep Imaging System
• Version Model Number: ThinPrep Imaging System 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	15420045501096 [Unit of Use]
GS1	25420045501093 [Primary]
GS1	35420045501090 [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 Imaging System]

• 25420045501093: ThinPrep Imaging System Slides
• 15420045508163: Thinprep Imaging System Computer
• 15420045508156: ThinPrep Imaging System Server
• 15420045508040: ThinPrep Imaging System Review Scope
• 15420045507265: ThinPrep Imaging System Workstation
• 15420045507258: ThinPrep Imaging System Workstation
• 15420045504103: ThinPrep Imaging System Workstation
• 15420045504097: ThinPrep Imaging System Workstation
• 15420045504080: ThinPrep Imaging System Workstation
• 15420045504042: ThinPrep Imaging System Computer
• 15420045504035: ThinPrep Imaging System Workstation
• 15420045501041: ThinPrep Imaging System Computer
• 15420045501034: ThinPrep Imaging System Computer
• 15420045501027: ThinPrep Imaging System Server
• 15420045501010: ThinPrep Imaging System Server
• 15420045501003: ThinPrep Imaging System Server
• 15420045500990: ThinPrep Imaging System Workstation
• 15420045500983: ThinPrep Imaging System Workstation
• 15420045500976: ThinPrep Imaging System Workstation
• 15420045500945: ThinPrep Imaging System Workstation
• 15420045500938: ThinPrep Imaging System Imaging Station
• 15420045500921: ThinPrep Imaging System Imaging Station
• 15420045500914: ThinPrep Imaging System Imaging Station
• 15420045500907: ThinPrep Imaging System Review Scope
• 15420045500891: ThinPrep Imaging System Review Scope
• 15420045512535: ThinPrep Imaging System Workstation
• 15420045512511: ThinPrep Imaging System Workstation
• 15420045513716: Thinprep Imaging System Computer
• 15420045515062: ThinPrep Imaging System Computer