Catalog Number

1262.30N

Brand Name

VYGON

Version/Model Number

1262.30N

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K010913,K010913,K010913

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

f2bc1c40-ff93-4396-8195-58e6c0e2a45a

Public Version Date

April 07, 2020

Public Version Number

1

DI Record Publish Date

March 30, 2020

Package DI Number

30849884002363

Quantity per Package

20

Contains DI Package

00849884002362

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-