Catalog Number

312.10

Brand Name

VYGON

Version/Model Number

312.10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 09, 2019

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

-

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

15bd6e15-8f93-4323-805d-3e67e6da7de5

Public Version Date

May 13, 2020

Public Version Number

5

DI Record Publish Date

September 13, 2016

Package DI Number

33660812003866

Quantity per Package

25

Contains DI Package

03660812003865

Package Discontinue Date

October 09, 2019

Package Status

Not in Commercial Distribution

Package Type

-