NovaSure SureSound NS2013KITUS

GUDID 15420045501126

Hologic, Inc.

Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal

• Primary Device ID: 15420045501126
• NIH Device Record Key: 9a66b689-26e8-4f06-9685-7a4a27b18f31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaSure SureSound
• Version Model Number: 2013
• Catalog Number: NS2013KITUS
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	15420045501126 [Primary]
GS1	25420045501123 [Package]; Package: BOX [1 Units]; In Commercial Distribution
GS1	35420045501120 [Package]; Contains: 25420045501123; Package: CARTON [3 Units]; In Commercial Distribution
GS1	45420045501127 [Package]; Contains: 35420045501120; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010013

FDA Product Code

• MNB: DEVICE, THERMAL ABLATION, ENDOMETRIAL

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[15420045501126]

Ethylene Oxide

[15420045501126]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-16

On-Brand Devices [NovaSure SureSound]

• 15420045501133: 2007
• 15420045501126: 2013