Waterpik UltraClear Fluoride Varnish (Bubblegum) - Fluoride Varnish, Box of 30 single dose (0.40ml) - WATER PIK, INC.

Duns Number:001804074

Device Description: Fluoride Varnish, Box of 30 single dose (0.40ml) (Bubblegum flavor)

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More Product Details

Catalog Number

20026682

Brand Name

Waterpik UltraClear Fluoride Varnish (Bubblegum)

Version/Model Number

20026682

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

2cd02b02-83c6-4972-a45e-b3cb2ed8cff4

Public Version Date

December 19, 2019

Public Version Number

1

DI Record Publish Date

December 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WATER PIK, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 293
2 A medical device with a moderate to high risk that requires special controls. 56