AccessGUDID - DEVICE: Synergy™ Ablation System (10840143902109)

GUDID

Device Identifier (DI) Information

Brand Name: Synergy™ Ablation System
Version or Model: OLL2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A000362
Company Name: ATRICURE, INC.

Primary DI Number: 10840143902109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006133784 *Terms of Use
Previous DI: 00818354010503

Device Description: Isolator Synergy™ Surgical Ablation System Open, Long Jaw, Left Curve

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?
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 [?]
P100046	003
P100046	004
P100046	005
P100046	006
P100046	007
P100046	008
P100046	009
P100046	010
P100046	011
P100046	012
P100046	013
P100046	016

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: b3e1a8b7-992e-45c0-b635-c311d7690d1c
Public Version Date: May 29, 2023
Public Version Number: 5
DI Record Publish Date: January 08, 2021