Duns Number:081325959
Device Description: MICRO VENTRICULAR BOLT PRESSURE MONITORING KIT
Catalog Number
1104HM
Brand Name
CAMINO®
Version/Model Number
110-4HM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K914735,K914735
Product Code
GWM
Product Code Name
Device, Monitoring, Intracranial Pressure
Public Device Record Key
39ad3aef-e865-436f-9c56-3ceef2b73048
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 07, 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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 302 |
| 3 | A medical device with high risk that requires premarket approval | 5 |