NovaSure SureSound - 2007
Device Description
A component of a radio-frequency (RF) hyperthermia system designed to be placed in the body to deliver radio-frequency (RF) energy to produce a systemic or local heating effect for the treatment of malignant or benign tumours, or other disease conditions. It is also referred to as an interstitial applicator or probe and is typically a catheter-enclosed conductor of RF energy that is introduced into the body either manually or endoscopically. It typically includes a thermometry component that monitors the temperature of the probe during operation. 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: True
Sterilization Methods:
- Ethylene Oxide
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: 15420045501133
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: 25420045501130
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15420045501133
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 35420045501137
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 25420045501130
Package Quantity: 3
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CARTON
Device Id: 45420045501134
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35420045501137
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX