ThinPrep 5000 Processor 71914-001

GUDID 15420045513945

Hologic, Inc.

Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD

• Primary Device ID: 15420045513945
• NIH Device Record Key: 2c8f3110-bc2a-40c9-8cf1-b2761abd275f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThinPrep 5000 Processor
• Version Model Number: TP-5000 Accessory Kit
• Catalog Number: 71914-001
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045513945 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-25

On-Brand Devices [ThinPrep 5000 Processor]

• 15420045504158: ThinPrep 5000 Processor
• 15420045513952: TP-5000 Autoloader Accessory Kit
• 15420045513945: TP-5000 Accessory Kit