Catalog Number

-

Brand Name

Jelco

Version/Model Number

408811

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

FOZ

Product Code Name

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

Public Device Record Key

2dd6a59f-de77-47a5-ab8b-87758046b189

Public Version Date

February 12, 2020

Public Version Number

2

DI Record Publish Date

August 07, 2019

Package DI Number

35019315118412

Quantity per Package

50

Contains DI Package

15019315118418

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case