Duns Number:692281073
Device Description: KOWA nonmyd AF is intended for use with retinal image capturing without requiring the pati KOWA nonmyd AF is intended for use with retinal image capturing without requiring the patients to take any mydriatic.
Catalog Number
-
Brand Name
KOWA nonmyd AF
Version/Model Number
K9L64K
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
PJZ
Product Code Name
Camera, Ophthalmic, General-Use
Public Device Record Key
a0efde9b-0e2a-47f6-a32f-64e82fbbbb73
Public Version Date
January 23, 2020
Public Version Number
1
DI Record Publish Date
January 15, 2020
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |