BIONIX DEVELOPMENT CORPORATION - DeClogger Starter Pack - BIONIX DEVELOPMENT CORPORATION

Duns Number:602736795

Device Description: DeClogger Starter Pack

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More Product Details

Catalog Number

10935

Brand Name

BIONIX DEVELOPMENT CORPORATION

Version/Model Number

DG-10935

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"

Yes

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

K905164

Product Code Details

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Record Status

Public Device Record Key

efa1193e-39c4-44a5-b246-e5d1d94c9b42

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 07, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIONIX DEVELOPMENT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 23