Catalog Number

921

Brand Name

BIONIX DEVELOPMENT CORPORATION

Version/Model Number

DG-921

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 01, 2017

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K905164,K905164

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

992d56c2-a6df-42af-a886-1014b36e8289

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 26, 2016

Package DI Number

08599110040041

Quantity per Package

10

Contains DI Package

08599110040096

Package Discontinue Date

February 01, 2017

Package Status

Not in Commercial Distribution

Package Type

box