DEVICE: NA (10886705024582)
Device Identifier (DI) Information
NA
260012
In Commercial Distribution
260012
Medos International Sàrl
260012
In Commercial Distribution
260012
Medos International Sàrl
Hip Access Kit No Blade Hip Access Kit No Blade, Hip 16G .065 X 6 Inches (1.65 x 152mm) Needle, Hip 16G .065 X 7 Inches (1.65 x 178mm) Needle, 2 Guide Wires, .049 x 17.5 Inches (1.25 x 445mm) Round End, Surgical Marker, Surgical Rule, Syringe 30mL
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? |
---|---|---|---|---|
44052 | Orthopaedic surgical procedure kit, non-medicated, single-use |
A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: less than 80 Degrees Fahrenheit |
Storage Environment Temperature: less than 26 Degrees Celsius |
Handling Environment Temperature: less than 26 Degrees Celsius |
Storage Environment Temperature: less than 80 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
4d4f96c2-9a42-479e-b7b8-a15eed4ecfb5
March 18, 2025
3
September 01, 2015
March 18, 2025
3
September 01, 2015
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
[?]
+1(800)255-2500
xx@xx.xx
xx@xx.xx