NovaSure NSV5KITUS-001

GUDID 15420045514300

Hologic, Inc.

Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode Radio-frequency endometrial-ablation system handpiece/electrode
Primary Device ID15420045514300
NIH Device Record Key48890500-6d3e-40e5-bd23-8a87b1ab9b13
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovaSure
Version Model NumberV5
Catalog NumberNSV5KITUS-001
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 Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045514300 [Primary]
GS125420045514307 [Package]
Package: BOX [1 Units]
In Commercial Distribution
GS135420045514304 [Package]
Contains: 25420045514307
Package: CARTON [3 Units]
In Commercial Distribution
GS145420045514301 [Package]
Contains: 35420045514304
Package: CARTON [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNBDevice, thermal ablation, endometrial

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


[15420045514300]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-12
Device Publish Date2021-07-02

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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