FAXITRON MAMMOTOME

GUDID 15420045516649

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 Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD

• Primary Device ID: 15420045516649
• NIH Device Record Key: 230159b3-546a-4d07-8101-2a9f019b4d15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FAXITRON MAMMOTOME
• Version Model Number: 120-807604
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045516649 [Unit of Use]
GS1	25420045516646 [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

Devices Manufactured by Hologic, Inc.

• 15420045512948 - AFFIRM™ CONTRAST BIOPSY: 2024-04-19 Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dim
• 15420045511446 - Panther Fusion®: 2024-04-15 Epstein-Barr virus (EBV) Primers ASR.
• 15420045511453 - Panther Fusion®: 2024-04-15 Epstein-Barr virus (EBV) Probe ASR.
• 15420045511552 - Panther Fusion®: 2024-04-15 Hologic GAS Plasmid Control.
• 15420045511576 - Panther Fusion®: 2024-04-15 Group A Strep (GAS) Probe ASR.
• 15420045511590 - Panther Fusion®: 2024-04-15 Group A Strep (GAS) Primers ASR.
• 15420045512122 - Panther Fusion®: 2024-04-15 Hologic EBV Plasmid Control.
• 15420045515529 - OMNI: 2024-02-27 The Omni Hysteroscopic Scissors are sterile, single-use, hand actuated hysteroscopic scissors that are intended to be used by a