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 |
20886705002174 - PANACRYL | 2024-06-03 Rotator Cuff EasyAnchor with PANACRYL Size 2 (5 metric) PANACRYL braided absorbable suture, 36 Inches (91 cm), double-armed with |
10886705008292 - FASTIN PANACRYL | 2024-06-03 FASTIN RC Anchor with PANACRYL Titanium Anchor with two Number 2 PANACRYL Poly (L-Lactide/Glycolide) Braided Absorbable Sutures, |
10886705009374 - VAPR | 2024-06-03 VAPR LD Suction Electrode 4 mm x 160 mm |
10886705009381 - VAPR | 2024-06-03 VAPR LP Suction Electrode 4 mm x 160 mm |
10886705000913 - NA | 2024-05-30 Rotator Cuff Anchor Threader Tab |
10886705001064 - LUPINE ORTHOCORD | 2024-05-30 LUPINE Loop Plus Anchor w/ORTHOCORD Poly Lactic Acid Absorbable Anchor, size 2 (5 metric) violet ORTHOCORD Braided Composite Sut |
10886705001071 - LUPINE ORTHOCORD | 2024-05-30 LUPINE Loop PLUS Dual Suture (DS) Anchor w/ORTHOCORD PLA Absorbable Anchor, with two size 2 (5 metric) ORTHOCORD braided composi |
10886705002412 - QUICKANCHOR PANACRYL | 2024-05-30 MINILOK QUICKANCHOR Plus (Number 2/0) Suture Poly (L-lactide) absorbable anchor, size 2/0 PANACRYL braided absorbable suture (3 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FMS VUE 85340228 4576230 Live/Registered |
FMS Future Medical System S.A. 2011-06-07 |