AccessGUDID - DEVICE: AtriCure Isolator Synergy EnCapture Clamp (10840143911767)

GUDID

Device Identifier (DI) Information

Brand Name: AtriCure Isolator Synergy EnCapture Clamp
Version or Model: EMH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A001433SB
Company Name: ATRICURE, INC.

Primary DI Number: 10840143911767
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006133784 *Terms of Use

Device Description: Isolator Synergy EnCapture Clamp

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?
64561	Epicardial radio-frequency ablation probe, open-surgery	A rigid handpiece and bipolar electrode assembly intended to deliver radio-frequency alternating current, from an appropriate cardiac radio-frequency ablation system generator, to ablate areas of the epicardium of a beating heart in the treatment of cardiac arrhythmias, during an open-surgical procedure. It is available in a variety of designs (e.g., clamp-like probe); it is not designed for endoscopic/minimally-invasive access. This is a single-use device.	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 [?]
K234151	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
Handling Environment Temperature: between -20 and 140 Degrees Fahrenheit
Handling 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: b881ac7f-f635-4210-ac46-5ef5c0d47e46
Public Version Date: March 24, 2025
Public Version Number: 1
DI Record Publish Date: March 14, 2025