Catalog Number

353385

Brand Name

S 45-JL

Version/Model Number

353385

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

DRB

Product Code Name

STYLET, CATHETER

Public Device Record Key

c4a2ddae-e709-41fe-b5e5-edf7bbfb1420

Public Version Date

October 11, 2022

Public Version Number

4

DI Record Publish Date

August 19, 2014

Package DI Number

04035479092603

Quantity per Package

10

Contains DI Package

04035479144951

Package Discontinue Date

October 05, 2022

Package Status

Not in Commercial Distribution

Package Type

case