Affirm Lateral Arm Upright Biopsy Accessory ASY-09644

GUDID 15420045506824

Hologic, Inc.

Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system

• Primary Device ID: 15420045506824
• NIH Device Record Key: 659d0f70-5290-46de-a1b4-c194d8d59fb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affirm Lateral Arm Upright Biopsy Accessory
• Version Model Number: ASY-09644
• Catalog Number: ASY-09644
• 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: true
• Serial Number: false
• 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	15420045506824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161575

FDA Product Code

• IZH: System, x-ray, mammographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-15

On-Brand Devices [Affirm Lateral Arm Upright Biopsy Accessory]

• 15420045506831: ASY-05205
• 15420045506824: ASY-09644
• 15420045506817: ASY-03723