| Primary Device ID | 00841506116099 |
| NIH Device Record Key | d8608458-ab14-41a2-b383-7f3b716e1fd8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ulna Shortening Plating System |
| Version Model Number | Ulnar Shortening, Cutting Guide, Proximal, Left |
| Catalog Number | CUTG-PRX-L |
| Company DUNS | 869056148 |
| Company Name | SKELETAL DYNAMICS L.L.C. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 00841506116099 [Primary] |
| HRS | Plate, fixation, bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
[00841506116099]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-21 |
| Device Publish Date | 2023-08-11 |
| 00841507516201 | K-Wire, Diamond Tip, 1.6mm x 127mm |
| 00841507516195 | Drill, 3.5mm x 40mm |
| 00841507416181 | Cutting Blade, Proximal |
| 00841507316177 | Cutting Blade, Distal |
| 00841507216163 | Cottle Osteotome, 2.0mm |
| 00841506916132 | Ulnar Shortening, Cutting Guide, Distal, Left |
| 00841506516097 | Ulnar Shortening, Cutting Guide, Proximal, Left |
| 00841506416083 | Ulnar Shortening, Cutting Guide, Proximal, Right |
| 00841506316666 | Ulnar Shortening Plating System Sterilization Tray |
| 00841506316079 | Ulnar Shortening Plate, Distal, Short, Left |
| 00841506216065 | Ulnar Shortening Plate, Distal, Short, Right |
| 00841506116051 | Forceps, Bone Holding Medium, Compression |
| 00841506116037 | Oblique Compression Hole Guide |
| 00841506115757 | Thread-In Drill Guide, FreeFix, 3.5mm |
| 00841506109985 | PROTEAN Plate Bending Pliers, Large |
| 00841506130705 | Drill, 3.5mm x 40mm, Reusable |
| 00841506117614 | Drill Guide, FreeFixTM, Ulnar Shortening |
| 00841506117577 | Forceps, Bone Holding Medium, Compression , Right |
| 00841506117560 | Forceps, Bone Holding Medium, Compression , Left |
| 00841506117089 | Ulnar Shortening Plating System |
| 00841506116662 | Ulnar Shortening Plating System Sterilization Tray |
| 00841506116204 | K-Wire, Single Diamond, 1.6mm x 127mm |
| 00841506116136 | Ulnar Shortening, Cutting Guide, Distal, Left |
| 00841506116129 | Ulnar Shortening, Cutting Guide, Distal, Right |
| 00841506116112 | Ulnar Shortening, Cutting Guide, Oblique, Proximal |
| 00841506116105 | Ulnar Shortening, Cutting Guide, Oblique, Proximal |
| 00841506116099 | Ulnar Shortening, Cutting Guide, Proximal, Left |
| 00841506116082 | Ulnar Shortening, Cutting Guide, Proximal, Right |
| 00841506116075 | Ulnar Shortening Plate, Distal, Short, Left |
| 00841506116068 | Ulnar Shortening Plate, Distal, Short, Right |
| 00841506109114 | Driver, Peg, Reuseable |
| 00841506108834 | Driver, Peg, Torque Limiting, Reusable |
| 00841506114446 | Ulnar Shortening Plate, Proximal, Long |
| 00841506114439 | Ulnar Shortening Plate, Proximal, Short |
| 00841506108841 | Drill, Solid Side Cutting, 2.0mm x 40mm (OUS) |
| 00841506117690 | Instrument, Hohmann Retractor, Double Ended |