DEVICE: Frame-Harness Strap Set (07290017702278)
Device Identifier (DI) Information
Frame-Harness Strap Set
A
In Commercial Distribution
XR-FRM-HRN
XACT ROBOTICS LTD
A
In Commercial Distribution
XR-FRM-HRN
XACT ROBOTICS LTD
Frame-Harness Strap Set
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? |
---|---|---|---|---|
64491 | Medical/surgical interventional tube/cable securement strap |
A strip of material in the form of tape/strap intended to be used to secure interventional patient tubes/cables to drapes or device covers in surgical/medical settings; it is not intended to attach to the patient and has no additional intended uses. It may be comprised of, e.g., an adhesive on one side to allow attachment to a drape/cover and Velcro on the other side for securing tubing/cables. This is a single-use device.
|
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
709649c8-c80f-48eb-8eab-b9aa25b1bfbc
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 |
---|---|---|---|---|---|
No Package DIs found |
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