Duns Number:539852079
Device Description: The Flextrak OR is intended for allowing transfer of a neurosurgical patient from OR suite The Flextrak OR is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients.
Catalog Number
-
Brand Name
FlexTrak OR Ingenia 1.5T
Version/Model Number
989603051341
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Product Code
LNH
Product Code Name
System, nuclear magnetic resonance imaging
Public Device Record Key
a4704c24-ce46-4427-9dc8-540bda328d13
Public Version Date
September 02, 2022
Public Version Number
6
DI Record Publish Date
September 23, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |