Duns Number:317138956
Device Description: The OCULUS Easyfield® has been designed for combined use as ascreening unit with all assoc The OCULUS Easyfield® has been designed for combined use as ascreening unit with all associated options for immediate follow-upexamination of suspicious findings. The most common examination gridsand strategies for the central visual field up to 30° can be accessed.The Easyfield® offers pre programmed combinations for often neededexamination routines. For example: Screening 24-2, SPARK Quick,Macula. You can also combine your own routines and then save them asa program.
Catalog Number
-
Brand Name
Easyfield C
Version/Model Number
15000
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
HOO
Product Code Name
Perimeter, Ac-Powered
Public Device Record Key
721d63f8-235a-413b-b54a-7b1b5b36bda2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2016
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |