Catalog Number

BP3016

Brand Name

Tutomesh™ bovine pericardium10x16 cm

Version/Model Number

BP3016

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

K081538

Product Code

DXZ

Product Code Name

PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Public Device Record Key

0e0b05e2-3a2b-462a-9ee4-c3532ed312bf

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

December 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-