Primary Device ID | 04547497771113 |
NIH Device Record Key | ac70ee51-03eb-4759-85bc-5433be4559af |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Mielscope |
Version Model Number | Mielscope (Floor Stand with Casters) |
Company DUNS | 690676978 |
Company Name | YOSHIDA DENTAL MFG. CO., LTD., THE |
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 |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 0.8 KiloPascal and 1.06 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04547497771113 [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 | 2023-12-06 |
Device Publish Date | 2023-11-28 |
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Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MIELSCOPE 97815594 not registered Live/Pending |
THE YOSHIDA DENTAL MFG. CO., LTD. 2023-02-28 |