Duns Number:437331574
Device Description: ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital imag ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriaticagent) with different outline colors.
Catalog Number
-
Brand Name
PROTOZ
Version/Model Number
01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
7b9b85c9-4fc4-4231-be0f-63a7b5e71031
Public Version Date
December 17, 2019
Public Version Number
1
DI Record Publish Date
December 09, 2019
Package DI Number
B667PROTOZ01
Quantity per Package
1
Contains DI Package
B667PROTOZ1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |