Catalog Number

JT120500000

Brand Name

5F STIFF COAXIAL DILATOR

Version/Model Number

JT120500000

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"

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

MPB

Product Code Name

Catheter, Hemodialysis, Non-Implanted

Public Device Record Key

175b49ea-4a51-4088-bd83-4ccbcfb2b0fc

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

July 20, 2015

Package DI Number

50810988020663

Quantity per Package

10

Contains DI Package

00810988020668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-