AccessGUDID - DEVICE: EPi-Sense ST Coagulation Device (10840143904585)

GUDID

Device Identifier (DI) Information

Brand Name: EPi-Sense ST Coagulation Device
Version or Model: EPiST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A001166
Company Name: ATRICURE, INC.

Primary DI Number: 10840143904585
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006133784 *Terms of Use

Device Description: No description.

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
OCM	Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 3 Centimeter

Device Record Status

Public Device Record Key: ca4534f5-6730-47fd-a964-92994cdbdb32
Public Version Date: October 03, 2022
Public Version Number: 1
DI Record Publish Date: September 23, 2022