CardioGenesis

Basic Information

• Brand Name: CardioGenesis
• Primary DI: 00877234000096
• Version / Model: NS2000
• Catalog Number: LSR-SG2100S
• Company Name: Artivion, Inc.
• Labeler DUNS: 119253177
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-12
• Public Version: 4
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 2a86def5-155e-4651-89ae-8ffe840a37dd

Device Description

SolarGen 2100s Holmium:YAG Laser Console

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNO	System, Laser, Transmyocardial Revascularization	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61149	Transmyocardial revascularization solid-state laser system	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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00877234000096	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P970029	009
P970029	012
P970029	015
P970029	028
P970029	032

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 14 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: It is recommended that the laser console be covered when stored and never stored in an area at or below freezing temperature (≤0°C or ≤32°F)