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 |
20886705000903 - NA | 2025-09-29 SuperAnchor Threader Tab |
10886705000951 - NA | 2025-09-29 SuperAnchor Threader Tab |
10886705001088 - LUPINE ETHIBOND | 2025-09-29 LUPINE Loop PLUS Anchor w/ETHIBOND PLA Absorbable Anchor, size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches ( |
10886705001958 - QUICKANCHOR PANACRYL | 2025-09-29 Rotator Cuff QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), with CP-2 needles, with dis |
10886705001989 - GII QUICKANCHOR PANACRYL | 2025-09-29 GII QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), double armed with CP-2 needles, with |
10886705001996 - QUICKANCHOR PANACRYL | 2025-09-29 Super QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), double armed with CP-2 needles, wi |
10886705002047 - ETHIBOND | 2025-09-29 Rotator Cuff EasyAnchor Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), with disposable inserter |
20886705002051 - ETHIBOND | 2025-09-29 Rotator Cuff EasyAnchor Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), with disposable inserter |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FMS VUE 85340228 4576230 Live/Registered |
FMS Future Medical System S.A. 2011-06-07 |