Primary Device ID | 10886705020591 |
NIH Device Record Key | 700c40e0-5c8e-4b27-a5a7-baf0a6c3552b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FMS VUE |
Version Model Number | 284002 |
Catalog Number | 284002 |
Company DUNS | 190572854 |
Company Name | DEPUY MITEK, LLC |
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 | false |
Serial Number | true |
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 |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 *Waste from Electrical and Electronic Equipment |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10886705020591 [Primary] |
HRX | ARTHROSCOPE |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2024-03-25 |
Device Publish Date | 2015-09-01 |
10886705010905 - TARGET | 2024-04-03 TARGET TENDON HARVESTER INSTRUMENT |
10886705010912 - TARGET | 2024-04-03 TARGET DISPOSABLE CUTTING TIPS |
10886705020591 - FMS VUE | 2024-03-25FMS VUE Fluid Management System |
10886705020591 - FMS VUE | 2024-03-25 FMS VUE Fluid Management System |
10886705013616 - INTRAFIX | 2023-11-02 FEMORAL INTRAFIX, HARD Includes (1) 7mm Sheath and (1) 6mm Screw 7mm-7.5mm x 23mm |
10886705013623 - INTRAFIX | 2023-11-02 FEMORAL INTRAFIX, STANDARD Includes (1) 7mm Sheath and (1) 7mm Screw 7mm-7.5mm x 23mm |
10886705013630 - INTRAFIX | 2023-11-02 FEMORAL INTRAFIX, HARD Includes (1) 8mm Sheath and (1) 7mm Screw 8mm-8.5mm x 23mm |
10886705013647 - INTRAFIX | 2023-11-02 FEMORAL INTRAFIX, STANDARD Includes (1) 8mm Sheath and (1) 8mm Screw 8mm-8.5mm x 23mm |
10886705013654 - INTRAFIX | 2023-11-02 FEMORAL INTRAFIX, HARD Includes (1) 9mm Sheath and (1) 8mm Screw 9mm-10mm x 23mm |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FMS VUE 85340228 4576230 Live/Registered |
FMS Future Medical System S.A. 2011-06-07 |