Duns Number:314546664
Device Description: iGUIDE® Software 2.2.1 is the software which controls the movement of the HexaPOD™ evo Mod iGUIDE® Software 2.2.1 is the software which controls the movement of the HexaPOD™ evo Module and monitors the correct position of the module.
Catalog Number
P10603-110
Brand Name
iGUIDE
Version/Model Number
P10603-110
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
K143485
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
89816146-ce0d-4b4e-be77-4c52593a2db2
Public Version Date
October 13, 2021
Public Version Number
3
DI Record Publish Date
February 24, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |