Catalog Number

-

Brand Name

Durashield®

Version/Model Number

AD31102

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 31, 2019

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

K982915,K982915,K982915

Product Code

LBH

Product Code Name

VARNISH, CAVITY

Public Device Record Key

0401e008-e13a-4e44-8e3b-385d3cbbfd52

Public Version Date

October 31, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

D687AD311022

Quantity per Package

4

Contains DI Package

D687AD311021

Package Discontinue Date

October 31, 2019

Package Status

Not in Commercial Distribution

Package Type

Case