The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre
NovaSure SureSound - 2013
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MNB
Device Name: Device, Thermal Ablation, Endometrial
Device Class: 3
Physical State: N/A
Definition: N/A
Submission Type ID: 2
Review Panel: OB
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 15420045501126
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 35420045501120
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 25420045501123
Package Quantity: 3
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CARTON
Device Id: 25420045501123
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15420045501126
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 45420045501127
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15420045501126
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
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