Biocor™ - St. Jude Medical Porcine Mitral Bioprosthetic - ST. JUDE MEDICAL, INC.

Duns Number:149818952

Device Description: St. Jude Medical Porcine Mitral Bioprosthetic Heart Valve

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More Product Details

Catalog Number

B100-29M-00

Brand Name

Biocor™

Version/Model Number

B100-29M-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

LWR

Product Code Name

heart-valve, non-allograft tissue

Device Record Status

Public Device Record Key

09ffd0ed-efac-4b26-b07c-27acbf0da600

Public Version Date

September 27, 2021

Public Version Number

6

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

-

"ST. JUDE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 70
2 A medical device with a moderate to high risk that requires special controls. 1429
3 A medical device with high risk that requires premarket approval 736