Duns Number:119253177
Device Description: SoloGrip III Handpiece Delivery System
Catalog Number
HP-SG3
Brand Name
CardioGenesis
Version/Model Number
HP-SG3
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P970029,P970029,P970029,P970029,P970029,P970029,P970029,P970029,P970029,P970029,P970029,P970029,P970029,P970029,P970029,P970029,P970029
Product Code
MNO
Product Code Name
System, Laser, Transmyocardial Revascularization
Public Device Record Key
1d8eedfc-406a-4f64-ae05-94b765158697
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 12, 2016
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. | 16 |
3 | A medical device with high risk that requires premarket approval | 8 |
U | Unclassified | 2 |