AtriCure Isolator Synergy EnCapture Clamp A001433SB

GUDID 30840143911761

Isolator Synergy EnCapture Clamp

ATRICURE, INC.

Epicardial radio-frequency ablation probe, open-surgery

• Primary Device ID: 30840143911761
• NIH Device Record Key: b881ac7f-f635-4210-ac46-5ef5c0d47e46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtriCure Isolator Synergy EnCapture Clamp
• Version Model Number: EMH
• Catalog Number: A001433SB
• Company DUNS: 006133784
• Company Name: ATRICURE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840143911767 [Primary]
GS1	30840143911761 [Package]; Contains: 10840143911767; Package: Box [1 Units]; In Commercial Distribution
GS1	50840143911765 [Package]; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234151

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-24
• Device Publish Date: 2025-03-14

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• 30840143911761 - AtriCure Isolator Synergy EnCapture Clamp: 2025-03-24Isolator Synergy EnCapture Clamp
• 30840143911761 - AtriCure Isolator Synergy EnCapture Clamp: 2025-03-24 Isolator Synergy EnCapture Clamp
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• 30840143911792 - AtriClip® FLEX-Mini™ LAA Exclusion System: 2024-09-09 LAA Exclusion System, ACHM45