Duns Number:690625850
Device Description: This Product is a device used as a heart positioner particularly for Off-Pump CABG (Corona This Product is a device used as a heart positioner particularly for Off-Pump CABG (Coronary Artery Bypass Grafting). Three (3) Suction Cups are attached to the surface of the heart by means of suction pressure applied to each one of them. Traction Tubes are pulled and clamped to the surgical drape by Forceps in order to fix the position of the heart.
Catalog Number
-
Brand Name
Tentacles NEO
Version/Model Number
MD-27320A
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MWS
Product Code Name
Stabilizer, Heart
Public Device Record Key
a4fd790b-4c64-4fde-87f0-34fc92b692eb
Public Version Date
May 30, 2022
Public Version Number
4
DI Record Publish Date
November 15, 2019
Package DI Number
24545499071693
Quantity per Package
1
Contains DI Package
04545499071699
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 211 |