Duns Number:969263979
Device Description: Kit containing 850007135003 (Emerald, oprifocon A, Blue) and 850007135010 (Emerald, oprif Kit containing 850007135003 (Emerald, oprifocon A, Blue) and 850007135010 (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
Not in Commercial Distribution
Commercial Distribution End Date
February 22, 2021
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
d4fc2ae3-3f6a-4960-9c20-201b65c097f6
Public Version Date
February 23, 2021
Public Version Number
3
DI Record Publish Date
February 29, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 8 |