Waterpik Getz Blue Core - Crown build-up material, single 5g syringe - WATER PIK, INC.

Duns Number:001804074

Device Description: Crown build-up material, single 5g syringe

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More Product Details

Catalog Number

041418-000

Brand Name

Waterpik Getz Blue Core

Version/Model Number

041418-000

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

-

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

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

7253643d-59c5-4037-82bd-f6a7f7144d86

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 27, 2016

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