Duns Number:268845728
Device Description: The DEX Device control handle is comprised of an ergonomic hand piece that can turn on its The DEX Device control handle is comprised of an ergonomic hand piece that can turn on its own axis thanks to the comfort joint. This axis can also allow the user to perform a complete manual prono-supination movement without moving his shoulder.The control handle has command buttons that activate the different degrees of freedom or the Arm. The three axes are motorized: Open/Close, Tilt (Left/Right), Rotation+/Rotation-.
Catalog Number
-
Brand Name
Control handle
Version/Model Number
P-1301
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
K191878
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
9fe8f5f8-d0be-4ce4-9ab7-90fd069fc1a8
Public Version Date
May 16, 2022
Public Version Number
1
DI Record Publish Date
May 06, 2022
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. | 10 |