DEVICE: Humeris Shoulder (03701037307274)
Device Identifier (DI) Information
Humeris Shoulder
911-0113
In Commercial Distribution
911-0113
FX SOLUTIONS
911-0113
In Commercial Distribution
911-0113
FX SOLUTIONS
ASYMETRIC GLENOID K-WIRE GUIDE SIZE M/L +3mm
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 44054 | Orthopaedic surgical procedure kit, non-medicated, reusable |
A collection of various orthopaedic surgical instruments, dressings and the necessary 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 reusable device.
|
Active | false |
| 35095 | Surgical drill guide, reusable |
A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LXH | Orthopedic Manual Surgical Instrument |
| FZX | Guide, 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 |
|---|
| Special Storage Condition, Specify: Store away from light and sunlight Store away from moisture |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
eac98307-59b9-41ed-ab70-306e99d11319
October 07, 2021
4
October 11, 2018
October 07, 2021
4
October 11, 2018
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
[?]
No Customer Contact currently defined