TRIDENT HD SPECIMEN RADIOGRAPHY

GUDID 15420045510425

Hologic, Inc.

Specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD

• Primary Device ID: 15420045510425
• NIH Device Record Key: 11111656-c373-4ce5-a1e4-5af5afa584b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIDENT HD SPECIMEN RADIOGRAPHY
• Version Model Number: TRI-00002
• 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: 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	15420045510425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182727

FDA Product Code

• MWP: Cabinet, x-ray system

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: 2020-03-12
• Device Publish Date: 2020-03-04

On-Brand Devices [TRIDENT HD SPECIMEN RADIOGRAPHY]

• 15420045512214: TRI-00002
• 15420045510425: TRI-00002