Catalog Number

00034010

Brand Name

VYGON

Version/Model Number

340.10

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

c2e8a682-10b7-4a87-a8b3-210e244d7f94

Public Version Date

May 17, 2022

Public Version Number

1

DI Record Publish Date

May 09, 2022

Package DI Number

53660812138326

Quantity per Package

18

Contains DI Package

33660812138322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case