Affirm Prone Biopsy System PBX-SYS-AFFIRM-2D

GUDID 15420045510845

Hologic, Inc.

Mammographic stereotactic biopsy system

• Primary Device ID: 15420045510845
• NIH Device Record Key: 3985da58-22da-4f99-aaa3-931d11752100
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affirm Prone Biopsy System
• Version Model Number: PBX-SYS-AFFIRM-2D
• Catalog Number: PBX-SYS-AFFIRM-2D
• Company DUNS: 139534114
• Company Name: Hologic, Inc.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	15420045510845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153486

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: 2019-09-27
• Device Publish Date: 2019-09-19

On-Brand Devices [Affirm Prone Biopsy System]

• 15420045506541: ASY-09175
• 15420045506534: ASY-08832
• 15420045506527: ASY-06886
• 15420045506510: PBX-SYS-AFFIRM-3D
• 15420045506503: PBX-SYS-AFFIRM-2D
• 15420045506497: ASY-08178
• 15420045506480: ASY-08176
• 15420045506473: ASY-08175
• 15420045506466: ASY-08174
• 15420045504738: 3D System Software
• 15420045504721: System Software
• 15420045510869: PBX-SYS-AFFIRM-2D
• 15420045510852: PBX-SYS-AFFIRM-2D
• 15420045510845: PBX-SYS-AFFIRM-2D