Catalog Number

518-027

Brand Name

LLD™

Version/Model Number

518-027

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 06, 2019

Issuing Agency

In HIBCC

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

Product Code

DRB

Product Code Name

Stylet, Catheter

Public Device Record Key

54321c45-8823-4006-b6c0-6a7ca32c79e4

Public Version Date

October 26, 2021

Public Version Number

5

DI Record Publish Date

August 19, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-