NovaSure

Basic Information

• Brand Name: NovaSure
• Primary DI: 15420045500853
• Version / Model: NovaSure Controller
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 65b1d9b8-24a1-4af9-85c4-ce8585dacf0a

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNB	DEVICE, THERMAL ABLATION, ENDOMETRIAL	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
40782	Tumour-therapy radio-frequency hyperthermia system	A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures around 43° Celsius) of the body using radio-frequency (RF) energy, for the treatment of malignant or benign tumours, or other disease conditions; it is not intended for direct tissue ablation. It includes an RF generator, controls, software and an RF applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045500853	GS1

Premarket Submissions

Submission Number	Supplement Number
P010013	055