Duns Number:808456037
Device Description: RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
Catalog Number
-
Brand Name
RetCam 3
Version/Model Number
RetCam 3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 2017
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
0c371463-b3b2-4251-ad33-7a7ba1c1dfcf
Public Version Date
February 09, 2021
Public Version Number
3
DI Record Publish Date
December 19, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |