AccessGUDID - DEVICE: The Heart Laser Disposable TMR kit (00860701000101)

GUDID

Device Identifier (DI) Information

Brand Name: The Heart Laser Disposable TMR kit
Version or Model: AC00012
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Novadaq Technologies Inc

Primary DI Number: 00860701000101
Issuing Agency: GS1
Commercial Distribution End Date: October 27, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 243730939 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNO	System, Laser, Transmyocardial Revascularization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: store in cool, dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e6638695-05f3-44d3-b86b-b2e149c27674
Public Version Date: October 30, 2023
Public Version Number: 4
DI Record Publish Date: September 17, 2014