Catalog Number

UFVM

Brand Name

Crosstex International

Version/Model Number

UFVM

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)

-

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

40cc510d-9d66-4661-9c2c-33834b805528

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 11, 2016

Package DI Number

50732224000331

Quantity per Package

5

Contains DI Package

10732224000333

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-