Varnal - Cavity varnish - CETYLITE INDUSTRIES INC

Duns Number:001283704

Device Description: Cavity varnish

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

0801

Brand Name

Varnal

Version/Model Number

0801

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LBH

Product Code Name

Varnish, Cavity

Device Record Status

Public Device Record Key

1055d4df-4487-44da-942a-086cf44e5f3a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CETYLITE INDUSTRIES INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 3