Multicare Platinum 8-004-0017

GUDID 15420045505926

Hologic, Inc.

Mammographic stereotactic biopsy system

• Primary Device ID: 15420045505926
• NIH Device Record Key: 86f345a3-32f6-4d9f-b01b-dc211000224d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multicare Platinum
• Version Model Number: 8-004-0017
• Catalog Number: 8-004-0017
• 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	15420045505926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030666

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: 2017-03-30

Devices Manufactured by Hologic, Inc.

• 15420045510470 - Panther Fusion®: 2024-07-22 Panther Fusion® Internal Control-X.
• 15420045510890 - Panther Fusion®: 2024-07-22 The Panther Fusion® GBS assay is an automated qualitative in vitro diagnostic test utilizing realtime PCR for detection of Grou
• 15420045510548 - 3Dimensions: 2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045510555 - 3Dimensions: 2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045510562 - 3Dimensions: 2024-07-08 Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray image
• 15420045510579 - 3Dimensions: 2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045510586 - 3Dimensions: 2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045510593 - 3Dimensions: 2024-07-08 Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray image