Thoratec® HeartMate 3™ System Controller - Thoratec Corporation

Duns Number:070156955

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More Product Details

Catalog Number

106531US

Brand Name

Thoratec® HeartMate 3™ System Controller

Version/Model Number

106531US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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 Details

Product Code

DSQ

Product Code Name

Ventricular (Assisst) Bypass

Device Record Status

Public Device Record Key

e8e0a664-c1d2-4966-b652-01a6d119e83f

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

August 30, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THORATEC CORPORATION" Characteristics
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