Catalog Number

639522AL

Brand Name

Fluor Protector S

Version/Model Number

639522AL

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

-

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

072e9319-4eb4-4683-8f86-7ceb7b3c72cd

Public Version Date

March 17, 2022

Public Version Number

3

DI Record Publish Date

November 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-