OtoClear® Tabletop WaterPik® Kit - Table Top WaterPik - Bionix, LLC

Duns Number:117844489

Device Description: Table Top WaterPik

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More Product Details

Catalog Number

7240

Brand Name

OtoClear® Tabletop WaterPik® Kit

Version/Model Number

7240

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

-

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

KCP

Product Code Name

SYRINGE, ENT

Device Record Status

Public Device Record Key

843ed24f-dd0b-47e1-9972-2058db0d10df

Public Version Date

January 17, 2022

Public Version Number

1

DI Record Publish Date

January 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIONIX, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 61
2 A medical device with a moderate to high risk that requires special controls. 27