Catalog Number

9510

Brand Name

BIONIX DEVELOPMENT CORPORATION

Version/Model Number

GF-09510

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"

-

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

K180605,K180605

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

1bf45f84-e1fc-4ad4-b032-53142ddbc5c2

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

March 02, 2019

Package DI Number

00859911004917

Quantity per Package

10

Contains DI Package

10859911004914

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX