Catalog Number

-

Brand Name

Vivid Seal Sealant material Low viscosity

Version/Model Number

D340164

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

EBC

Product Code Name

Sealant, Pit And Fissure, And Conditioner

Public Device Record Key

2355288a-9fa8-4db8-bf43-b75251b2d7bd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-