AFFIRM™ SPECIMEN IMAGING

GUDID 15420045512931

Hologic, Inc.

Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system

• Primary Device ID: 15420045512931
• NIH Device Record Key: 45bd3439-527f-4b12-9fc3-e03ea9f47576
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFFIRM™ SPECIMEN IMAGING
• Version Model Number: AFFIRM™ SPECIMEN IMAGING
• Company DUNS: 139534114
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045512931 [Primary]

FDA Product Code

• IZH: System, x-ray, mammographic

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: 2021-07-19
• Device Publish Date: 2021-07-10

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