Catalog Number

-

Brand Name

Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear

Version/Model Number

Emerald

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

-

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

NUU

Product Code Name

Lens, Contact, Orthokeratology, Overnight

Public Device Record Key

dcad5a0e-4beb-45f6-acad-5db893a98f4e

Public Version Date

October 26, 2020

Public Version Number

4

DI Record Publish Date

July 19, 2019

Package DI Number

85000713500140

Quantity per Package

1

Contains DI Package

00850007135041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Flat Pack Pillow Pk