Catalog Number

-

Brand Name

Jelco

Version/Model Number

407800

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 07, 2020

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

294709a9-fa47-474d-8a99-206d88791e45

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

January 12, 2017

Package DI Number

30351688072089

Quantity per Package

200

Contains DI Package

10351688072085

Package Discontinue Date

August 07, 2020

Package Status

Not in Commercial Distribution

Package Type

Box