AccessGUDID - DEVICE: Multifunctional Ablation Generator (30840143904473)

GUDID

Device Identifier (DI) Information

Brand Name: Multifunctional Ablation Generator
Version or Model: MAG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A001372
Company Name: ATRICURE, INC.

Primary DI Number: 30840143904473
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006133784 *Terms of Use

Device Description: The MAG is an electro-mechanical ablation system that utilizes both monopolar and bipolar radio frequency (RF) energy to ablate biological tissue. The MAG can be used with a variety of AtriCure Handpieces to perform cardiac ablations.

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?
60784	Cardiac radio-frequency ablation system generator	An electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCM	Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221358	000
P100046	013
P100046	016
P200002	004
P200002	005

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
Storage Environment Temperature: between -40 and 60 Degrees Celsius
Special Storage Condition, Specify: Transit Temperature between -29 to 60 Degrees Celsius
Special Storage Condition, Specify: Transit Humidity between 30% to 85% relative humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e5799c0-7436-48a2-b591-ffd6e213b6f5
Public Version Date: May 29, 2023
Public Version Number: 2
DI Record Publish Date: February 21, 2023