- Physicians Office Resource

SolarGen 2100s Holmium:YAG Laser Console
CardioGenesis - NS2000

Device Description

A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod [typically yttrium-aluminium-garnet doped with holmium (Ho:YAG)] to emit a high-power laser beam intended for transmyocardial revascularization surgical procedures (open surgical approach); it does not include frequency-doubling technology. It includes a light source, controls/foot-switch and may include the handpiece/guide. It emits a midinfrared wavelength, and may be used with a handpiece capable of injecting agents/materials into the heart (e.g., stem cells).

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

80.00
10.00

Special Storage Condition, Specify

It is recommended that the laser console be covered when stored and never stored in an area at or below freezing temperature (less than or equal to 0°C or 32°F)

Storage Environment Humidity - Percent (%) Relative Humidity

80.00
10.00

Storage Environment Temperature - Degrees Celsius

30.00
14.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: MNO

Device Name: System, Laser, Transmyocardial Revascularization

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 00877234000096

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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