Catalog Number

686770AN

Brand Name

Helioseal Clear F F Plus

Version/Model Number

686770AN

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)

Yes

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

2f9af1dd-2b90-478c-9b5b-07eb02c89282

Public Version Date

March 17, 2022

Public Version Number

3

DI Record Publish Date

November 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-