DEVICE: The Heart Laser Disposable TMR kit (00860701000101)

Device Identifier (DI) Information

The Heart Laser Disposable TMR kit
AC00012
In Commercial Distribution

Novadaq Technologies Inc
00860701000101
GS1

1
243730939 *Terms of Use
Sterile disposable kit which includes TMR handpieces, arm drape, cleaning swabs, heart diagram and markers
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
MNO System, Laser, Transmyocardial Revascularization
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: store in cool, dry place
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

e6638695-05f3-44d3-b86b-b2e149c27674
March 29, 2018
2
September 17, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
1-800-230-3352
xxx@xxx.xxx
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