AccessGUDID - DEVICE: 815012US (25420045505398)

GUDID

Device Identifier (DI) Information

Brand Name: 815012US
Version or Model: 815012US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 815012US
Company Name: Hologic, Inc.

Primary DI Number: 25420045505398
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
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?
66633	Radio-frequency endometrial-ablation system generator	An electrically-powered device intended to produce radio-frequency (RF) energy at a predetermined power (based on uterus size) for coagulation/ablation of the endometrium with a handpiece/electrode (not included) to treat menorrhagia. The RF generator is also intended to facilitate carbon dioxide (CO2) delivery from a CO2 cartridge for assessment of uterine cavity integrity (intactness), and includes a suction pump intended to facilitate constant contact between the electrode and endometrium. It is intended to monitor tissue impedance [resistance of the tissue to alternating electrical current (AC)] to automatically interrupt ablation at a pre-set impedance threshold.	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	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 4dcca622-4c17-45e0-8cfc-0d02ff2d8fb2
Public Version Date: August 11, 2023
Public Version Number: 4
DI Record Publish Date: September 08, 2016