Duns Number:262951353
Device Description: PRESSIO ICP MONITORING KIT, VENTRICULAR TUNNELING
Catalog Number
-
Brand Name
SOPHYSA
Version/Model Number
PSO-VT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062584
Product Code
GWM
Product Code Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Public Device Record Key
6065f579-bd62-420a-a12a-e0b45d0ec2b8
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
July 20, 2016
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. | 223 |