Duns Number:153647979
Device Description: The Clarity System delivers significant capabilities to improve the contrast, color, satur The Clarity System delivers significant capabilities to improve the contrast, color, saturation and sharpness of surgical video.
Catalog Number
ZMED-2XYAC-019
Brand Name
Clarity
Version/Model Number
ZMED-2XYAC-019
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130929,K130929
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
d1802849-209d-4247-84a6-fdc62a163c3a
Public Version Date
May 19, 2020
Public Version Number
5
DI Record Publish Date
September 08, 2016
Package DI Number
00869958000124
Quantity per Package
1
Contains DI Package
00869958000117
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case of each
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |