Catalog Number

1261.306A

Brand Name

VYGON

Version/Model Number

1261.306A

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

K041468,K041468

Product Code

LJS

Product Code Name

Catheter,intravascular,therapeutic,long-term greater than 30 days

Public Device Record Key

1c15a862-f15c-4839-83ca-9544cc949a24

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

November 21, 2017

Package DI Number

38498840011189

Quantity per Package

10

Contains DI Package

08498840011188

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-