REGULATOR 67RAXNA CRYOFLEX NA

REGULATOR 67RAXNA CRYOFLEX NA
Cardioblate® CryoFlex® - 67RAXNA

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00643169183759

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