Duns Number:065016344
Device Description: Camera Control Unit, Pixa Console 4K with Image Capture & Light Engine
Catalog Number
85-10-4010
Brand Name
Pixa
Version/Model Number
85-10-4010
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
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
0167f888-c2ed-49e1-a2a6-1f023165ef5b
Public Version Date
August 31, 2018
Public Version Number
3
DI Record Publish Date
March 06, 2018
Package DI Number
00853460007368
Quantity per Package
1
Contains DI Package
00853460007047
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SNS Label
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |