NovaSure

GUDID 15420045500860

Hologic, Inc.

Tumour-therapy radio-frequency hyperthermia system Tumour-therapy radio-frequency hyperthermia system Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator Radio-frequency endometrial-ablation system generator
Primary Device ID15420045500860
NIH Device Record Keyba9ae143-9f88-4b3d-aa41-f3c2ee34fb7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovaSure
Version Model NumberNovaSure Controller
Company DUNS018925968
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment Atmospheric PressureBetween 141 Millimeter of Mercury and 780 Millimeter of Mercury
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045500860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNBDEVICE, THERMAL ABLATION, ENDOMETRIAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-02

On-Brand Devices [NovaSure]

154200455011402000
154200455011192013
15420045500860NovaSure Controller
15420045500853NovaSure Controller
25420045514307V5
15420045514300V5
15420045514294V5
15420045515154V5

Trademark Results [NovaSure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NOVASURE
NOVASURE
90566013 not registered Live/Pending
Hologic, Inc.
2021-03-08
NOVASURE
NOVASURE
75569943 2513050 Live/Registered
CYTYC CORPORATION
1998-10-14

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