Primary Device ID | 04547497757049 |
NIH Device Record Key | 4048c16e-95b4-4f11-8ef3-82f25cb7e10e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PreXion3D Eclipse |
Version Model Number | XP77 |
Company DUNS | 690676978 |
Company Name | YOSHIDA DENTAL MFG. CO., LTD., THE |
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 | false |
OTC Over-The-Counter | false |
Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
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