Catalog Number

-

Brand Name

Infusion Catheter

Version/Model Number

MC4L-8S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 29, 2021

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"

Yes

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

FOZ

Product Code Name

Catheter,intravascular,therapeutic,short-term less than 30 days

Public Device Record Key

f854a967-5aa6-426c-a0da-fa6ca02db8c1

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

October 23, 2015

Package DI Number

50884908029364

Quantity per Package

10

Contains DI Package

00884908029369

Package Discontinue Date

January 29, 2021

Package Status

Not in Commercial Distribution

Package Type

box