DEVICE: XACT Robotics: Harness (XL) (07290017702193)
Device Identifier (DI) Information
XACT Robotics: Harness (XL)
A
In Commercial Distribution
XR-XL-HRN
XACT ROBOTICS LTD
A
In Commercial Distribution
XR-XL-HRN
XACT ROBOTICS LTD
Extra-Large Harness
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61131 | Radiological general body-part positioner |
A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JAK | System, X-Ray, Tomography, Computed |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K191332 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a5c20b0a-27ea-464e-9afe-b9ad83eedf63
January 27, 2023
1
January 19, 2023
January 27, 2023
1
January 19, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
17290017702190 | 5 | 07290017702193 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+18883179228
customerservice@xactrobotics.com
customerservice@xactrobotics.com