- Physicians Office Resource

PEN 49313 CARDIOBLATE PEN FT
Cardioblate™ - 49313

Device Description

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.

Environmental Conditions

Storage Environment Humidity - Percent (%) Relative Humidity

85.00
5.00

Storage Environment Temperature - Degrees Celsius

25.00
N/A

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OCL

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

Device Class: 2

Physical State: The device tip delivers energy to provide cutting, coagulation, and/or ablation of the contacted tissue

Definition: Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device energy source used to provide cutting, coagulation and/or ablation may be radio frequency (RF), cryogenic, laser or ultrasound

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Cardiac tissue.

Regulation Number: 878.4400

Third Party Flag: Y

Medical Specialty: SU

Device Identifiers

Device Id: 00643169997967

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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