Catalog Number

-

Brand Name

LUCEA LED®

Version/Model Number

ARDLCA506001A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 29, 2020

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K113679

Product Code

FTD

Product Code Name

Lamp, surgical

Public Device Record Key

566196b7-0075-42fb-8eed-6c8c7dc66f0e

Public Version Date

March 03, 2022

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-