Duns Number:690625850
Device Description: This Product is a device used as a heart positioner particularly for Off-Pump CABG (Corona
Catalog Number
-
Brand Name
Tentacles
Version/Model Number
MD-27310
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
4ad059d7-4066-4d9c-af89-e738066e5aba
Public Version Date
May 30, 2022
Public Version Number
4
DI Record Publish Date
May 26, 2020
Package DI Number
24545499071198
Quantity per Package
1
Contains DI Package
04545499071194
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 |