Catalog Number

518-020

Brand Name

LLD™ #3

Version/Model Number

518-020AA

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

K043401,K043401

Product Code

DRB

Product Code Name

Stylet, Catheter

Public Device Record Key

2fd35435-57af-489f-9e94-7273f2db12d6

Public Version Date

October 26, 2021

Public Version Number

4

DI Record Publish Date

February 06, 2015

Package DI Number

20813132020785

Quantity per Package

3

Contains DI Package

00813132020781

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box