Duns Number:070156955
Device Description: Thread Protectors
Catalog Number
106532US
Brand Name
Thoratec® HeartMate 3™
Version/Model Number
106532US
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
P160054,P160054
Product Code
DSQ
Product Code Name
Ventricular (assist) bypass
Public Device Record Key
0e3e04f3-77c0-458c-a0d3-47e7d2186b85
Public Version Date
May 31, 2019
Public Version Number
1
DI Record Publish Date
May 23, 2019
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 |
|---|---|---|
| 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. | 18 |
| 3 | A medical device with high risk that requires premarket approval | 156 |