ThinPrep PRD-07065

GUDID 15420045514614

Hologic, Inc.

General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline

• Primary Device ID: 15420045514614
• NIH Device Record Key: 35febd55-b605-4870-9761-ab33d8dc78d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThinPrep
• Version Model Number: CytoLyt Cup
• Catalog Number: PRD-07065
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045514614 [Primary]
GS1	25420045514611 [Package]; Package: BOX [50 Units]; In Commercial Distribution

FDA Product Code

• LEA: PRESERVATIVE, CYTOLOGICAL

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: 2021-11-30
• Device Publish Date: 2021-11-22

On-Brand Devices [ThinPrep]

• 25420045510064: FILTER, THINPREP UROCYTE 100 PACK
• 25420045509990: THINPREP MICROSCOPE, ARCLESS, 72pk
• 25420045509679: NON-GYN Slides
• 25420045509662: NON-GYN Filters, 100 pack
• 15420045510166: Bluing II
• 15420045510159: Rinse II
• 15420045510128: EA
• 15420045510104: OG
• 15420045509702: Bluing 4L PKG. PRODUCT
• 15420045509696: Nuclear 4L PKG. PRODUCT
• 15420045509689: Rinse 4L PKG. PRODUCT
• 15420045508484: UroCyte Vial
• 15420045508460: UroCyte Vial
• 15420045508453: CytoLyt Tube
• 15420045508446: CytoLyt Cup
• 15420045508408: CytoLyt Quart
• 15420045508361: PRESERVCYT QUART
• 15420045508354: CellFyx Device
• 15420045508316: PRESERVCYT VIAL
• 25420045510057: THINPREP SLIDES UROCYTE, 100 pk
• 25420045508467: UroCyte Vial
• 15420045514775: PRESERVCYT VIAL
• 15420045514621: UroCyte Vial
• 15420045514614: CytoLyt Cup
• 15420045514607: CytoLyt Tube