CardioGenesis HP-PRL5

GUDID 00877234000119

Pearl 5.0 Handpiece Delivery System

Cryolife, Inc.

Transmyocardial revascularization laser system beam guide

• Primary Device ID: 00877234000119
• NIH Device Record Key: 2785ad9d-59a7-435d-9e0b-de09dedf4bf9
• Commercial Distribution Discontinuation: 2017-05-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CardioGenesis
• Version Model Number: HP-PRL5
• Catalog Number: HP-PRL5
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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 *clean, dry environment under conditions that protect against extremes in temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *clean, dry environment under conditions that protect against extremes in temperature and humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877234000119 [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: true

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