Catalog Number

310.04

Brand Name

VYGON

Version/Model Number

310.04

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 2018

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

2203111c-2bee-4834-9d00-c3c084bbf6b2

Public Version Date

May 13, 2020

Public Version Number

5

DI Record Publish Date

September 13, 2016

Package DI Number

53660812003488

Quantity per Package

12

Contains DI Package

33660812003484

Package Discontinue Date

June 15, 2018

Package Status

Not in Commercial Distribution

Package Type

-