Duns Number:314546664
Device Description: iGUIDE® Software 2.2 is the software which controls the movement of the the HexaPOD™ evo iGUIDE® Software 2.2 is the software which controls the movement of the the HexaPOD™ evo Module and monitors the correct position of the module
Catalog Number
P10603-109
Brand Name
iGUIDE
Version/Model Number
P10603-109
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 12, 2021
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
2afc8cff-aad4-4471-a6a0-b8007cb9c0e1
Public Version Date
October 13, 2021
Public Version Number
3
DI Record Publish Date
August 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |