CardioGenesis LSR-SG2100S

GUDID 00877234000096

SolarGen 2100s Holmium:YAG Laser Console

Cryolife, Inc.

Transmyocardial revascularization solid-state laser system

• Primary Device ID: 00877234000096
• NIH Device Record Key: 2a86def5-155e-4651-89ae-8ffe840a37dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioGenesis
• Version Model Number: NS2000
• Catalog Number: LSR-SG2100S
• Company DUNS: 119253177
• Company Name: Cryolife, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *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)
• Special Storage Condition, Specify: Between 0 and 0 *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)
• Special Storage Condition, Specify: Between 0 and 0 *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)
• Special Storage Condition, Specify: Between 0 and 0 *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)
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877234000096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970029

FDA Product Code

• MNO: System, Laser, Transmyocardial Revascularization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-12

On-Brand Devices [CardioGenesis]

• 00877234000119: Pearl 5.0 Handpiece Delivery System
• 00877234000102: SoloGrip III Handpiece Delivery System
• 00877234000096: SolarGen 2100s Holmium:YAG Laser Console