NovaSure NS2013US

GUDID 15420045501119

Hologic, Inc.

Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal

• Primary Device ID: 15420045501119
• NIH Device Record Key: 4f4976c9-121a-4be7-a517-e2675237f439
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaSure
• Version Model Number: 2013
• Catalog Number: NS2013US
• 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: 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

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045501119 [Primary]
GS1	25420045501116 [Package]; Package: BOX [1 Units]; In Commercial Distribution
GS1	35420045501113 [Package]; Contains: 25420045501116; Package: CARTON [3 Units]; In Commercial Distribution
GS1	45420045501110 [Package]; Contains: 35420045501113; 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

[15420045501119]

Ethylene Oxide

[15420045501119]

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]

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