3f® - THV 1000-21 3F AORTIC BIO 21MM 2PC HLDR - MEDTRONIC 3F THERAPEUTICS, INC.

Duns Number:079527232

Device Description: THV 1000-21 3F AORTIC BIO 21MM 2PC HLDR

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More Product Details

Catalog Number

-

Brand Name

3f®

Version/Model Number

1000-21

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2017

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

P060025

Product Code Details

Product Code

LWR

Product Code Name

heart-valve, non-allograft tissue

Device Record Status

Public Device Record Key

e9e9014d-2e37-439f-be0a-adf987f5fb16

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC 3F THERAPEUTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
3 A medical device with high risk that requires premarket approval 18