Catalog Number

340.12

Brand Name

VYGON

Version/Model Number

340.12

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

-

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

c13409c8-8741-4985-8c20-1fdaa509ebe7

Public Version Date

October 16, 2019

Public Version Number

2

DI Record Publish Date

June 26, 2019

Package DI Number

53660812112609

Quantity per Package

18

Contains DI Package

33660812112605

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case