Duns Number:969263979
Device Description: Kit containing 850007135072(Emerald Toric, opirfocon A, Blue) and 850007135089(Emerald Tor Kit containing 850007135072(Emerald Toric, opirfocon A, Blue) and 850007135089(Emerald Toric, oprifocon A, Green)
Catalog Number
-
Brand Name
Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
Version/Model Number
Emerald Toric
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 02, 2020
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
P040029,P040029,P040029,P040029,P040029,P040029,P040029,P040029,P040029,P040029,P040029,P040029,P040029,P040029,P040029,P040029
Product Code
NUU
Product Code Name
Lens, Contact, Orthokeratology, Overnight
Public Device Record Key
8099e2ee-b770-42bc-9ddc-7a3c13b97fa1
Public Version Date
March 03, 2020
Public Version Number
3
DI Record Publish Date
July 19, 2019
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 |