The Heart Laser Disposable TMR kit

GUDID 00860701000101

Sterile disposable kit which includes TMR handpieces, arm drape, cleaning swabs, heart diagram and markers

Novadaq Technologies Inc

Transmyocardial revascularization laser system beam guide

• Primary Device ID: 00860701000101
• NIH Device Record Key: e6638695-05f3-44d3-b86b-b2e149c27674
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Heart Laser Disposable TMR kit
• Version Model Number: AC00012
• Company DUNS: 243730939
• Company Name: Novadaq Technologies 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx
• Phone: 1-800-230-3352
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *store in cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860701000101 [Primary]

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: 2018-09-10
• Device Publish Date: 2014-09-17

Devices Manufactured by Novadaq Technologies Inc

• 20858701006326 - SPY-PHI System: 2024-02-29 SPY-PHI drape
• 10858701006220 - PINPOINT PAQ®: 2023-10-30
• 20858701006258 - SPY®: 2023-10-30
• 10858701006299 - NOVADRAPE®: 2023-10-30 sterile drape
• 10858701006176 - PINPOINT PAQ®: 2020-11-06
• 10858701006237 - PINPOINT PAQ®: 2020-11-06
• 10858701006244 - LUNA PAQ®: 2020-11-06
• 20858701006265 - SPY PAQ®: 2020-11-06