AccessGUDID - DEVICE: FARASTAR™ (00191506042899)

GUDID

Device Identifier (DI) Information

Brand Name: FARASTAR™
Version or Model: M004PF61M401D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M004PF61M401D
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00191506042899
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Pulsed Field Ablation Generator

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:	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?
65067	Cardiac irreversible electroporation system generator	A cardiac-dedicated mains electricity (AC-powered) device designed to generate microsecond electrical pulses to produce irreversible cell membrane electroporation (a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death) for the selective nonthermal ablation of cardiac tissues. It includes controls (e.g., foot-switch), user interface, and is designed to connect to appropriate cardiac mapping equipment and catheter (not included).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QZI	Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P230030	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: f597dfca-6abc-4125-a391-3fc193900815
Public Version Date: February 19, 2024
Public Version Number: 1
DI Record Publish Date: February 09, 2024