AccessGUDID - DEVICE: AtriCure Isolator Synergy EnCompass Clamp and Guide System (10840143905209)

GUDID

Device Identifier (DI) Information

Brand Name: AtriCure Isolator Synergy EnCompass Clamp and Guide System
Version or Model: OSH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A001144SB
Company Name: ATRICURE, INC.

Primary DI Number: 10840143905209
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006133784 *Terms of Use
Previous DI: 10840143904127

Device Description: Surgical Ablation System Open, Standard Jaw with Glidepath Magnetic Guide

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":	Yes
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
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210477	000

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
Storage Environment Temperature: between -20 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ed7cd4e-3a77-4d8d-b399-01ec49589572
Public Version Date: January 12, 2023
Public Version Number: 1
DI Record Publish Date: January 04, 2023