Duns Number:543066376
Device Description: This device is used to create digital colour photographic images of the ocular fundus thro This device is used to create digital colour photographic images of the ocular fundus through the pupil, to aid in diagnosing and monitoring retinal pathology.
Catalog Number
-
Brand Name
NA
Version/Model Number
APS-AER
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
HKI
Product Code Name
Camera, Ophthalmic, Ac-Powered
Public Device Record Key
fd63567a-7d65-4a78-b748-8cf624ed67bf
Public Version Date
April 23, 2018
Public Version Number
1
DI Record Publish Date
March 22, 2018
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |