NovaBright - 0.4mL 5% Sodium Fluoride Varnish (Mint) - 250 - NANOVA BIO MATERIALS INC

Duns Number:006084093

Device Description: 0.4mL 5% Sodium Fluoride Varnish (Mint) - 250 Units

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More Product Details

Catalog Number

14213-250

Brand Name

NovaBright

Version/Model Number

14213-250

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

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 Details

Product Code

LBH

Product Code Name

VARNISH, CAVITY

Device Record Status

Public Device Record Key

8de82064-5d57-4734-a1af-507ff5081722

Public Version Date

March 25, 2020

Public Version Number

4

DI Record Publish Date

January 02, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NANOVA BIO MATERIALS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 136