Primary Device ID | B366U1OM200FR01 |
NIH Device Record Key | f0f056f2-45e6-4e34-98ca-042863f06242 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MICROSCOPE |
Version Model Number | R00 |
Catalog Number | U1OM200F |
Company DUNS | 043555079 |
Company Name | Ecleris |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 786-483-7490 |
ytzielo@ecleris.com | |
Phone | 786-483-7490 |
ytzielo@ecleris.com | |
Phone | 786-483-7490 |
ytzielo@ecleris.com | |
Phone | 786-483-7490 |
ytzielo@ecleris.com | |
Phone | 786-483-7490 |
ytzielo@ecleris.com | |
Phone | 786-483-7490 |
ytzielo@ecleris.com | |
Phone | 786-483-7490 |
ytzielo@ecleris.com | |
Phone | 786-483-7490 |
ytzielo@ecleris.com | |
Phone | 786-483-7490 |
ytzielo@ecleris.com | |
Phone | 786-483-7490 |
ytzielo@ecleris.com | |
Phone | 786-483-7490 |
ytzielo@ecleris.com | |
Phone | 786-483-7490 |
ytzielo@ecleris.com |
Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B366U1OM200FR01 [Primary] |
EPT | Microscope, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-08-02 |
Device Publish Date | 2024-07-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MICROSCOPE 90468066 not registered Live/Pending |
Zhou Hong Mei 2021-01-15 |
MICROSCOPE 90027117 not registered Live/Pending |
Microscope HC, LLC 2020-06-29 |
MICROSCOPE 86088050 5220613 Live/Registered |
Schlumberger Technology Corporation 2013-10-10 |
MICROSCOPE 78026652 not registered Dead/Abandoned |
Procter & Gamble Company, The 2000-09-19 |
MICROSCOPE 75144039 not registered Dead/Abandoned |
American Dialogue, Inc. 1996-08-02 |
MICROSCOPE 74584632 not registered Dead/Abandoned |
Capstone Technology, Inc. 1994-10-12 |