Catalog Number

-

Brand Name

Durashield® CV

Version/Model Number

0031105FG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

LBH

Product Code Name

VARNISH, CAVITY

Public Device Record Key

84c2f801-35a0-4767-9b38-d0b56d67b4d2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

D6870031105FG2

Quantity per Package

4

Contains DI Package

D6870031105FG1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case