ThinPrep 2000 Processor

GUDID 15420045500839

Hologic, Inc.

Microscope slide maker IVD Microscope slide maker IVD

• Primary Device ID: 15420045500839
• NIH Device Record Key: 95cbee55-146b-4a64-8cb3-c30b934fbb13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThinPrep 2000 Processor
• Version Model Number: ThinPrep 2000 Processor
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045500839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• 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: 2014-09-02

On-Brand Devices [ThinPrep 2000 Processor]

• 15420045507005: ThinPrep 2000 Processor
• 15420045500839: ThinPrep 2000 Processor