Catalog Number

60-2011

Brand Name

Mapcath stylet

Version/Model Number

60-2011

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

LJS

Product Code Name

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

Public Device Record Key

8d1ec068-7d5d-4a2d-afe2-0aee364fdfca

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 04, 2016

Package DI Number

20815149025265

Quantity per Package

10

Contains DI Package

10815149025268

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-