Catalog Number

-

Brand Name

N/A

Version/Model Number

103-0304

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

K011535,K011535

Product Code

MJN

Product Code Name

Catheter, intravascular occluding, temporary

Public Device Record Key

ff5bf874-99d4-4291-9ad4-cd3a280688df

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

April 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-