DEVICE: Self-Reinforced Technology (10845854017166)
Device Identifier (DI) Information
Self-Reinforced Technology
BXS6216
In Commercial Distribution
BXS6216
Conmed Corporation
BXS6216
In Commercial Distribution
BXS6216
Conmed Corporation
1.5 mm Bone Fixation Kit, Self-Reinforced Technology Diameter 1.5 X 16 mm
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? |
---|---|---|---|---|
45037 | Orthopaedic bone pin, bioabsorbable |
A device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HWC | Screw, fixation, bone |
MAI | Fastener, fixation, biodegradable, soft tissue |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: KEEP DRY |
Storage Environment Temperature: less than 40 Degrees Celsius |
Storage Environment Temperature: less than 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 1.5 Millimeter |
Length: 16 Millimeter |
Device Record Status
4afdd3aa-f928-496a-aca6-b7b9087aece3
April 18, 2024
5
October 18, 2017
April 18, 2024
5
October 18, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30845854017160 | 2 | 10845854017166 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00845854017169
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(866)426-6633
CustomerExperience@conmed.com
CustomerExperience@conmed.com