N/A - C10MR10MSTKS
Device Description
A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.
Environmental Conditions
- Do not use if package is damaged
- Do not use if package is opened
- Keep Dry
- Keep out of direct sunlight
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OAD
Device Name: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Device Class: 3
Physical State: The device is an ablation catheter that features electrodes through which thermal energy is delivered.
Definition: For the treatment of atrial flutter.
Submission Type ID: 2
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: The ablation catheter delivers energy to the specific region of the heart in order to create lesions that will treat the patient of atrial flutter.
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: N
Target Area: Heart
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 10846835000184
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