Cellient® 71305-001

GUDID 15420045513938

Cellient® Filter-Cassette Kit

Hologic, Inc.

Histology tissue cassette IVD, laboratory processing, single-use

• Primary Device ID: 15420045513938
• NIH Device Record Key: f9569dd4-92a6-49fc-8cc1-99dbdaaa400b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cellient®
• Version Model Number: Cellient Filter Cassette Kit
• Catalog Number: 71305-001
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045513938 [Primary]

FDA Product Code

• IDT: APPARATUS, MELTING POINT, PARAFFIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-08-19
• Device Publish Date: 2022-12-14

Devices Manufactured by Hologic, Inc.

• 15420045517097 - DIGITAL DIAGNOSTICS SYSTEM: 2025-07-25 Computer to operate the Genius™ Review Station.
• 15420045517851 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
• 15420045517882 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
• 15420045517899 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
• 15420045517905 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
• 15420045517912 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
• 15420045517929 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
• 15420045517936 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b