Duns Number:083171244
Device Description: The Integra Pole Mount Sliding Bracket can be used with Integra External Ventricular Drain The Integra Pole Mount Sliding Bracket can be used with Integra External Ventricular Drainage (EVD) systems and may also be used as a replacement assembly or accessory component. The Integra Pole Mount Sliding Bracket is used to secure the EVD system to the rail of the Pole Mount Assembly.
Catalog Number
INS301
Brand Name
Integra™ Pole Mount Sliding Bracket
Version/Model Number
INS301
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
K062599
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
1312ede5-9aff-417f-ac25-f57467d6ce25
Public Version Date
October 03, 2022
Public Version Number
6
DI Record Publish Date
September 22, 2015
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |