Catalog Number

-

Brand Name

E.DL SPXL LENS

Version/Model Number

196 745

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

-

Product Code

HJK

Product Code Name

Lens, Contact, Polymethylmethacrylate, Diagnostic

Public Device Record Key

ee5e5cd6-7fdc-4af6-88fc-c04a3cddc9c2

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

10841668111854

Quantity per Package

10

Contains DI Package

00841668111857

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box