AccessGUDID - DEVICE: Genesys HTA System (08714729809326)

GUDID

Device Identifier (DI) Information

Brand Name: Genesys HTA System
Version or Model: M006580010
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M006580010
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729809326
Issuing Agency: GS1
Commercial Distribution End Date: January 19, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Genesys HTA System 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?
40784	Extravascular-circulation hyperthermia system	An assembly of devices designed to produce and control heated fluids circulated within a vessel applied to the body (e.g., vest, mattress, jacket, band, pad, body wrap, catheter, probe) for systemic or localized heating to treat malignant tumours, benign growths, or other disease-related conditions. It is typically a computer-controlled configuration used for curative or palliative treatment by causing the temperature of the whole body, localized areas, or targeted organs to rise to temperatures greater than 43? Celsius. It is typically used in an oncology department.	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: 9a4ea681-73d4-46c2-8ed1-664616a303c5
Public Version Date: May 20, 2021
Public Version Number: 6
DI Record Publish Date: September 24, 2014