NovaSure
GUDID 15420045500860
Hologic, Inc.
Tumour-therapy radio-frequency hyperthermia system| Primary Device ID | 15420045500860 |
| NIH Device Record Key | ba9ae143-9f88-4b3d-aa41-f3c2ee34fb7a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NovaSure |
| Version Model Number | NovaSure Controller |
| Company DUNS | 018925968 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 141 Millimeter of Mercury and 780 Millimeter of Mercury |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045500860 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-02 |
On-Brand Devices [NovaSure]
| 15420045501140 | 2000 |
| 15420045501119 | 2013 |
| 15420045500860 | NovaSure Controller |
| 15420045500853 | NovaSure Controller |
| 25420045514307 | V5 |
| 15420045514300 | V5 |
| 15420045514294 | V5 |
| 15420045515154 | V5 |
Trademark Results [NovaSure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVASURE 90566013 not registered Live/Pending |
Hologic, Inc. 2021-03-08 |
 NOVASURE 75569943 2513050 Live/Registered |
CYTYC CORPORATION 1998-10-14 |
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