Catalog Number

-

Brand Name

LUMEX Essentials

Version/Model Number

81218

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IMP

Product Code Name

Cushion, Wheelchair

Public Device Record Key

45537104-eed6-408b-a948-7408124b5c24

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

September 06, 2019

Package DI Number

M368812182

Quantity per Package

4

Contains DI Package

M368812181

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box