Duns Number:989925396
Device Description: The Integra Camino Flex Extension Cable is used to connect the Integra Camino Flex Cathete The Integra Camino Flex Extension Cable is used to connect the Integra Camino Flex Catheter to the Integra Camino ICP Monitor. It is an eight foot long silicone cable, with circular PEI (polyetherimide) connectors and a Ferrite clamp on suppressor.
Catalog Number
-
Brand Name
Camino®
Version/Model Number
FLEXEXT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 2020
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"
Yes
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
K121159
Product Code
GWM
Product Code Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Public Device Record Key
018c63ef-4faf-4cd6-bb03-b56bf212a632
Public Version Date
April 06, 2020
Public Version Number
4
DI Record Publish Date
December 29, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |
| U | Unclassified | 114 |