Primary Device ID | EFIAE0120041 |
NIH Device Record Key | e691c1fa-c25c-4dc2-af4f-cba4202bd19f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FlexPointer 1.5 |
Version Model Number | 1 |
Company DUNS | 312623008 |
Company Name | Fiagon GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
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 | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com | |
Phone | +13364282241 |
support@fiagon.com |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
HIBCC | EFIAE0120040 [Direct Marking] |
HIBCC | EFIAE0120041 [Primary] |
PGW | Ear, Nose, And Throat Stereotaxic Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
[EFIAE0120041]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-03-30 |
Device Publish Date | 2016-08-09 |
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