Celero Introducer CELERO INTRO-12

GUDID 05420045503222

Hologic, Inc.

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• Primary Device ID: 05420045503222
• NIH Device Record Key: 9b426050-850b-4b33-8415-1d3fd8b27192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celero Introducer
• Version Model Number: CELERO INTRO-12
• Catalog Number: CELERO INTRO-12
• 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: true
• 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: 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05420045503222 [Primary]
GS1	15420045503229 [Package]; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K034021

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

Sterilization

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

[05420045503222]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-11

Devices Manufactured by Hologic, Inc.

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• 15420045511491 - Panther Fusion®: 2024-06-18 Varicella zoster virus (VZV) Probe ASR.
• 15420045512115 - Panther Fusion®: 2024-06-18 Hologic CMV Plasmid Control.
• 15420045512146 - Panther Fusion®: 2024-06-18 Hologic VZV Plasmid Control.
• 15420045513877 - DIGITAL DIAGNOSTICS SYSTEM: 2024-06-17 The Genius™ digital imager creates digital images of glass slides as part of the Genius™ digital diagnostics system.
• 15420045513884 - DIGITAL DIAGNOSTICS SYSTEM: 2024-06-17 Computer to operate the Genius™ Digital Imager.