ATEC SAPPHIRE C

GUDID 15420045504714

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

• Primary Device ID: 15420045504714
• NIH Device Record Key: 8dbe8bb7-e3b9-4988-b9ed-eead044c509a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATEC SAPPHIRE C
• Version Model Number: ATEC SAPPHIRE C
• Company DUNS: 153623137
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045504714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042290

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

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: 2015-10-26

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• 15420045511491 - Panther Fusion®: 2024-06-18 Varicella zoster virus (VZV) Probe ASR.
• 15420045512115 - Panther Fusion®: 2024-06-18 Hologic CMV Plasmid Control.
• 15420045512146 - Panther Fusion®: 2024-06-18 Hologic VZV Plasmid Control.
• 15420045513877 - DIGITAL DIAGNOSTICS SYSTEM: 2024-06-17 The Genius™ digital imager creates digital images of glass slides as part of the Genius™ digital diagnostics system.
• 15420045513884 - DIGITAL DIAGNOSTICS SYSTEM: 2024-06-17 Computer to operate the Genius™ Digital Imager.