Duns Number:969263979
Device Description: Emerald, oprifocon A, Green
Catalog Number
-
Brand Name
Euclid Systems Orthokeratology (oprifocon 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
2d6626c7-b45d-4191-94bd-449a749dccb9
Public Version Date
October 26, 2020
Public Version Number
4
DI Record Publish Date
July 19, 2019
Package DI Number
85000713500119
Quantity per Package
1
Contains DI Package
00850007135010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Flat Pack Pillow Pk
Device Class | Device Class Description | No of Devices |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 8 |