815012US 815012US

GUDID 25420045505398

Hologic, Inc.

Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal

• Primary Device ID: 25420045505398
• NIH Device Record Key: 4dcca622-4c17-45e0-8cfc-0d02ff2d8fb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 815012US
• Version Model Number: 815012US
• Catalog Number: 815012US
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 5
• 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: true
• 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	15420045505391 [Unit of Use]
GS1	25420045505398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010013

FDA Product Code

• MNB: DEVICE, THERMAL ABLATION, ENDOMETRIAL

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: 2016-09-08

Devices Manufactured by Hologic, Inc.

• 15420045517585 - DIGITAL DIAGNOSTICS SYSTEM: 2025-04-11 Computer to operate the Genius™ Review Station.
• 15420045516991 - Aptima®: 2025-03-24 Aptima® SARS-CoV-2 Assay, 100 test, box 1 of 2 (2°C to 8°C box).
• 15420045517004 - Aptima®: 2025-03-24 Aptima® SARS-CoV-2 Assay, 100 test, box 2 of 2 (15°C to 30°C box).
• 15420045517035 - Aptima®: 2025-03-24 Aptima® SARS-CoV-2 Assay Controls Kit.
• 15420045517059 - Aptima®: 2024-12-27 Aptima® BV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test
• 15420045517066 - Aptima®: 2024-12-27 Aptima® BV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® BV assay is an in vitro nucleic acid amplification te
• 15420045517073 - Aptima®: 2024-12-27 Aptima® CV/TV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplificatio
• 15420045517080 - Aptima®: 2024-12-27 Aptima® CV/TV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplificat