Primary Device ID | 07630003590401 |
NIH Device Record Key | 9afd9ef1-f8f3-4f45-8e3a-127e98e8f1a9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Leica GLOW800 |
Version Model Number | 000000000010448962 |
Company DUNS | 480198725 |
Company Name | Leica Microsystems (Schweiz) AG |
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 | true |
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(847)8213462 |
adam.blunier@leica-microsystem |
Device Size Text, specify | 0 |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Special Storage Condition, Specify | Between 0 and 0 * |
Handling Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07630003590401 [Primary] |
IZI | System, x-ray, angiographic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-10-18 |
Device Publish Date | 2018-09-17 |
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