Duns Number:243730939
Device Description: Sterile disposable kit which includes TMR handpieces, arm drape, cleaning swabs, heart dia Sterile disposable kit which includes TMR handpieces, arm drape, cleaning swabs, heart diagram and markers
Catalog Number
-
Brand Name
The Heart Laser Disposable TMR kit
Version/Model Number
AC00012
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MNO
Product Code Name
System, Laser, Transmyocardial Revascularization
Public Device Record Key
e6638695-05f3-44d3-b86b-b2e149c27674
Public Version Date
September 10, 2018
Public Version Number
3
DI Record Publish Date
September 17, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |
| 3 | A medical device with high risk that requires premarket approval | 1 |