Duns Number:260631677
Device Description: Control box of PhotonVue system
Catalog Number
-
Brand Name
PHOTONVUE CONTROL BOX
Version/Model Number
PVUECCB-1.0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 08, 2018
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132475
Product Code
OWN
Product Code Name
Confocal Optical Imaging
Public Device Record Key
2e0be256-ce72-43f2-9232-81b47798ae7a
Public Version Date
February 01, 2022
Public Version Number
4
DI Record Publish Date
January 19, 2018
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |