Duns Number:547954649
Device Description: mainly measures spherical power, cylindrical power and axis of the cylindrical lens as wel mainly measures spherical power, cylindrical power and axis of the cylindrical lens as well as contact lens. It marks on the uncut lens and checks if the spectacle lens is correctly mounted.
Catalog Number
-
Brand Name
Focimeter
Version/Model Number
CCQ-400
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HLM
Product Code Name
Instrument, Measuring, Lens, Ac-Powered
Public Device Record Key
44acb910-ebfe-4ec5-b7f1-5a738cfb6791
Public Version Date
March 11, 2021
Public Version Number
1
DI Record Publish Date
March 03, 2021
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |