Catalog Number

466k100A

Brand Name

Vascular Kit

Version/Model Number

466k100A

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

OFB

Product Code Name

Catheter Guide Wire Kit

Public Device Record Key

e7445ac5-bd03-4da9-bf36-bbaa4e609114

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

10886333200006

Quantity per Package

5

Contains DI Package

00886333200009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box