The Heart Laser Disposable TMR kit

Basic Information

• Brand Name: The Heart Laser Disposable TMR kit
• Primary DI: 00860701000101
• Version / Model: AC00012
• Company Name: Novadaq Technologies Inc
• Labeler DUNS: 243730939
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-17
• Public Version: 4
• Public Version Date: 2023-10-30
• Public Version Status: Update
• Public Device Record Key: e6638695-05f3-44d3-b86b-b2e149c27674
• Distribution End Date: 2023-10-27

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
61171	Transmyocardial revascularization laser system beam guide	A sterile, flexible, probe-like device intended to be connected to a cardiac laser system for the delivery of laser energy directly onto the heart during transmyocardial revascularization surgery (open surgical approach). It includes fibreoptic materials whereby a distal laser fibre of a specific width is intended to penetrate myocardium to create channels for the promotion of angiogenesis; it may include distal needles/tubing to allow injection of agents into the myocardium. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860701000101	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: store in cool, dry place