NovaSure

GUDID 15420045500853

Hologic, Inc.

Tumour-therapy radio-frequency hyperthermia system

• Primary Device ID: 15420045500853
• NIH Device Record Key: 65b1d9b8-24a1-4af9-85c4-ce8585dacf0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaSure
• Version Model Number: NovaSure Controller
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045500853 [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: 2014-09-02

On-Brand Devices [NovaSure]

• 15420045501140: 2000
• 15420045501119: 2013
• 15420045500860: NovaSure Controller
• 15420045500853: NovaSure Controller
• 25420045514307: V5
• 15420045514300: V5
• 15420045514294: V5
• 15420045515154: V5