Primary Device ID | 00810112597844 |
NIH Device Record Key | b3853e7d-8f60-4a2f-acc0-0e281e9c140c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MiniBunion |
Version Model Number | MiniBunion Non-Locking Drill Guide |
Catalog Number | 280012PKG |
Company DUNS | 058864308 |
Company Name | CROSSROADS EXTREMITY SYSTEMS |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810112597844 [Primary] |
FZX | Guide, Surgical, Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
[00810112597844]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-08-15 |
Device Publish Date | 2024-08-07 |
00815432029228 | The MiniBunion Plating System is intended for fixation of osteotomies and corrective procedures |
00810112597875 | MiniBunion Saw Guide |
00810112597868 | MIS Bunion Plate Inserter |
00810112597851 | MiniBunion Instruments Tray |
00810112597844 | MiniBunion Non-Locking Drill Guide |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MINIBUNION 88244621 not registered Live/Pending |
Crossroads Extremity Systems 2018-12-28 |