Catalog Number

UFVPM

Brand Name

Crosstex International

Version/Model Number

UFVPM

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)

-

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

9240befb-2e17-4585-acb7-e9bb48dd0b2c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 11, 2017

Package DI Number

D682UFVPM4P

Quantity per Package

12

Contains DI Package

D682UFVPM2N

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-