815012US 815012US

GUDID 25420045505398

Hologic, Inc.

Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator

• 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.

• 15420045512948 - AFFIRM™ CONTRAST BIOPSY: 2024-04-19 Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dim
• 15420045511446 - Panther Fusion®: 2024-04-15 Epstein-Barr virus (EBV) Primers ASR.
• 15420045511453 - Panther Fusion®: 2024-04-15 Epstein-Barr virus (EBV) Probe ASR.
• 15420045511552 - Panther Fusion®: 2024-04-15 Hologic GAS Plasmid Control.
• 15420045511576 - Panther Fusion®: 2024-04-15 Group A Strep (GAS) Probe ASR.
• 15420045511590 - Panther Fusion®: 2024-04-15 Group A Strep (GAS) Primers ASR.
• 15420045512122 - Panther Fusion®: 2024-04-15 Hologic EBV Plasmid Control.
• 15420045515529 - OMNI: 2024-02-27 The Omni Hysteroscopic Scissors are sterile, single-use, hand actuated hysteroscopic scissors that are intended to be used by a