Duns Number:946065000
Device Description: Blanks (button blanks for use in the manufacture of RGP contact lenses)Color: Blue, Green, Blanks (button blanks for use in the manufacture of RGP contact lenses)Color: Blue, Green, or ClearNumber of Units
Catalog Number
-
Brand Name
SGP 3
Version/Model Number
unifocon A
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
P900001
Product Code
HQD
Product Code Name
Lens, Contact (Other Material) - Daily
Public Device Record Key
8516ae91-7fbf-4521-a2e7-50af176e3f60
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |