Waterpik Ultra Thin & Clear Varnish 20032768

GUDID D686200327640

5% Sodium Fluoride, Strawberry flavor

WATER PIK, INC.

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Primary Device IDD686200327640
NIH Device Record Keybb2a6f16-dcdf-48f6-a0cb-00974e772903
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaterpik Ultra Thin & Clear Varnish
Version Model Number20032768
Catalog Number20032768
Company DUNS001804074
Company NameWATER PIK, INC.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com
Phone(800) 525-2020
Emailprofessional@waterpik.com

Device Dimensions

Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD686200327640 [Unit of Use]
HIBCCD686200327643 [Primary]
HIBCCD686200327683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBHVarnish, Cavity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-28
Device Publish Date2023-08-18

On-Brand Devices [Waterpik Ultra Thin & Clear Varnish]

D6862003067705% Sodium Fluoride, Mint flavor
D6862003067605% Sodium Fluoride, Strawberry flavor
D6862003067505% Sodium Fluoride, Bubblegum flavor
D6862003067405% Sodium Fluoride, Melon flavor
D6862003067305% Sodium Fluoride, Variety Pack - 25 ea - Bubblegum, Melon, Strawberry, and Mint flavors
D6862003277005% Sodium Fluoride, Variety Pack - 25 ea - Bubblegum, Melon, Strawberry, and Mint flavors
D6862003276505% Sodium Fluoride, Mint flavor
D6862003276405% Sodium Fluoride, Strawberry flavor
D6862003276305% Sodium Fluoride, Bubblegum flavor
D6862003276205% Sodium Fluoride, Melon flavor
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