Primary Device ID | 00810112597035 |
NIH Device Record Key | 56558c83-eb70-4c53-a1a6-56d2a7fb6830 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TriLeap Lower Extremity Plating System |
Version Model Number | Lateral Ti Talar Neck Plate, Linear |
Catalog Number | 04.900.057 |
Company DUNS | 058864308 |
Company Name | CROSSROADS EXTREMITY SYSTEMS |
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 | true |
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 | 00810112597035 [Primary] |
HRS | Plate, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
[00810112597035]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-02-29 |
Device Publish Date | 2024-02-21 |
00850038154455 - DynaBunion | 2024-05-30 DynaBunion Plate STD 15mm - Left Sterile |
00850038154479 - DynaBunion | 2024-05-30 DynaBuion Plate STD 15mm - Right Sterile |
00850038154462 - DynaBunion | 2024-05-09 DynaBunion Plate STD 18mm - Left Sterile |
00850038154486 - DynaBunion | 2024-05-09 DynaBunion Plate STD 18mm Right |
00850038154646 - DynaBunion | 2024-05-09 DynaBunion IMA Reducer - Disposable Sterile |
00810112592245 - TriLeap Lower Extremity Anatomic Plating System | 2024-03-04 Screw Rack for 2.0/2.5/3.0 Screws |
00810112592252 - TriLeap Lower Extremity Anatomic Plating System | 2024-03-04 Screw Rack for 3.0/3.5/4.0 Screws |
00810112592269 - TriLeap Lower Extremity Anatomic Plating System | 2024-03-04 14MM Cannulated Cone Reamer |