ACCY 65TC1 CRYOFLEX TANK CARRIER
Cardioblate® CryoFlex™ - 65TC1
Device Description
An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.
Environmental Conditions
- Storage and Operating Humidity: 10% to 95%, noncondensing
- Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
- Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
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 IdentifiersDevice Id: 00643169183827
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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