5% Clear Sodium Fluoride Varnish Melon 500ct - 5% Clear Sodium Fluoride Varnish Melon 500ct - DARBY DENTAL SUPPLY, LLC

Duns Number:825137818

Device Description: 5% Clear Sodium Fluoride Varnish Melon 500ct

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More Product Details

Catalog Number

9510029

Brand Name

5% Clear Sodium Fluoride Varnish Melon 500ct

Version/Model Number

9510029

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 01, 2018

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)

Yes

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

144b2a35-4a8b-424e-b7ca-5fd7a557a655

Public Version Date

February 07, 2019

Public Version Number

5

DI Record Publish Date

September 28, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DARBY DENTAL SUPPLY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1457
2 A medical device with a moderate to high risk that requires special controls. 194
U Unclassified 2