ThinPrep Imaging System

GUDID 15420045504097

Hologic, Inc.

Laboratory instrument/analyser application software IVD

• Primary Device ID: 15420045504097
• NIH Device Record Key: deb92714-02dd-4a91-9540-2c4fa09206e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThinPrep Imaging System
• Version Model Number: ThinPrep Imaging System Workstation
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045504097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020002
• Premarket Approval: P020002

FDA Product Code

• MNM: READER, 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: 2014-09-08

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