Catalog Number

-

Brand Name

BlueLEX

Version/Model Number

LD-105

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EBZ

Product Code Name

Activator, Ultraviolet, For Polymerization

Public Device Record Key

cf926880-11bd-45a8-b6dc-766280101f9d

Public Version Date

March 21, 2022

Public Version Number

3

DI Record Publish Date

April 30, 2018

Package DI Number

14711552010012

Quantity per Package

15

Contains DI Package

04711552010015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box