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

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• 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

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• 10858701006237 - PINPOINT PAQ®: 2020-11-06
• 10858701006244 - LUNA PAQ®: 2020-11-06
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