NovaSure

Basic Information

• Brand Name: NovaSure
• Primary DI: 15420045514300
• Version / Model: V5
• Catalog Number: NSV5KITUS-001
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-02
• Public Version: 2
• Public Version Date: 2023-12-14
• Public Version Status: Update
• Public Device Record Key: 48890500-6d3e-40e5-bd23-8a87b1ab9b13

Device Description

The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
66632	Radio-frequency endometrial-ablation system handpiece/electrode	A combined handpiece and bipolar electrode array intended to be introduced into the uterine cavity to deliver radio-frequency (RF) current for coagulation/ablation of the endometrium to treat menorrhagia. It is designed to be inserted without imaging whereby the electrode array is expanded in situ to achieve full endometrium contact. It includes tubing for delivery of carbon dioxide (CO2) to assess uterine cavity integrity (intactness), and for suction to clear and maintain endometrium contact within the cavity; ablation is automatically interrupted at a pre-set impedance threshold. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045514300	GS1
Package	45420045514301	GS1	CARTON	1	In Commercial Distribution
Package	25420045514307	GS1	BOX	1	In Commercial Distribution
Package	35420045514304	GS1	CARTON	3	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P010013	000