AFFIRM™ SPECIMEN IMAGING

GUDID 15420045512931

Hologic, Inc.

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.

• 15420045516236 - Envision: 2025-11-21
• 15420045516243 - Envision: 2025-11-21
• 15420045516250 - Envision: 2025-11-21
• 15420045516267 - Envision: 2025-11-21
• 15420045516274 - Envision: 2025-11-21
• 15420045516281 - Envision: 2025-11-21
• 15420045516304 - Envision: 2025-11-21
• 15420045516311 - Envision: 2025-11-21