AccessGUDID - DEVICE: Genesys HTA Control Unit (00850033976014)

GUDID

Device Identifier (DI) Information

Brand Name: Genesys HTA Control Unit
Version or Model: M006580010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M006580010
Company Name: Minerva Surgical, Inc.

Primary DI Number: 00850033976014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829616478 *Terms of Use
Previous DI: 08714729809326

Device Description: Genesys HTA 115V Control Unit

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
58863	Circulating-fluid endometrial-ablation control unit	A hand-held, electrically-powered device designed to produce and regulate heat in a circulating fluid for ablation (typically at a temperature of approximately 150°C) of the interior lining of the uterus (endometrium) for the treatment of dysfunctional uterine bleeding (menorrhagia). It is intended to be used with a disposable catheter component which circulates the heated fluid. It typically provides computerized control of treatment settings, including time, pressure, and temperature, and consists of an LCD user-interface to display treatment stage information and controls to initiate treatment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNB	Device, Thermal Ablation, Endometrial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 5c370c16-9acd-406a-804a-af458606faa0
Public Version Date: June 16, 2022
Public Version Number: 1
DI Record Publish Date: June 08, 2022