Catalog Number

921

Brand Name

BIONIX DEVELOPMENT CORPORATION

Version/Model Number

DG-921

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

54e329ec-1999-4561-a072-1959f19f88cf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 01, 2017

Package DI Number

00859911004252

Quantity per Package

10

Contains DI Package

10859911004259

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box