FAXITRON CORE 04-4126

GUDID 15420045516625

Container with a base and a lid to hold surgical specimen sample for the purpose of x-ray imaging that sample

Hologic, Inc.

Tissue specimen x-ray system IVD

• Primary Device ID: 15420045516625
• NIH Device Record Key: 3c09d64f-cc1e-4db2-af65-d6b311a63e7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FAXITRON CORE
• Version Model Number: 04-4126
• Catalog Number: 04-4126
• Company DUNS: 139534114
• Company Name: Hologic, Inc.
• Device Count: 25
• 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: 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045516625 [Unit of Use]
GS1	25420045516622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082432

FDA Product Code

• MWP: Cabinet, x-ray system

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: 2023-04-19
• Device Publish Date: 2023-04-11

On-Brand Devices [FAXITRON CORE]

• 15420045514218: COREVISION 5X10
• 15420045516625: Container with a base and a lid to hold surgical specimen sample for the purpose of x-ray imagin