Thoratec® HeartMate 3™ Tunneling Lance and Handle - Thoratec Corporation

Duns Number:070156955

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More Product Details

Catalog Number

106533US

Brand Name

Thoratec® HeartMate 3™ Tunneling Lance and Handle

Version/Model Number

106533US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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

8b4009a5-dddf-4ca8-b1a8-729eb9eb139f

Public Version Date

February 07, 2019

Public Version Number

5

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