Catalog Number

B13245

Brand Name

4-5 CM CONTURAFLEX MLB CATHETER w/BLUNT TIP INTRO

Version/Model Number

B13245

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

K081079

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Public Device Record Key

676ab373-3f76-45ac-b15d-18d9ca6c6d85

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-