Catalog Number

-

Brand Name

IRIS

Version/Model Number

4846-428

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

-

Product Code

LBH

Product Code Name

Varnish, Cavity

Public Device Record Key

6354bf12-7ddb-4af4-8f22-abb350ec1033

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10366975000740

Quantity per Package

56

Contains DI Package

00366975000743

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case