AccessGUDID - DEVICE: NovaSure (15420045514294)

GUDID

Device Identifier (DI) Information

Brand Name: NovaSure
Version or Model: V5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NSV5US-001
Company Name: Hologic, Inc.

Primary DI Number: 15420045514294
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018925968 *Terms of Use

Device Description: The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66632	Radio-frequency endometrial-ablation system handpiece/electrode	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNB	Device, thermal ablation, endometrial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P010013	081

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 72a63589-a6bf-410e-8980-cc7164c45ab6
Public Version Date: May 23, 2024
Public Version Number: 3
DI Record Publish Date: July 02, 2021