Guidewire
GUDID EFIAE0129111
The product GuideWire is a product variant of a navigated probe for image guided surgical procedures. The GuideWire is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The GuideWire is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system| Primary Device ID | EFIAE0129111 |
| NIH Device Record Key | 7d201353-bd0e-4a85-8ddf-31cf282f3d66 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guidewire |
| 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 |
Customer Support Contacts
| 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 | |
| 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 |
Operating and Storage Conditions
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EFIAE0129110 [Direct Marking] |
| HIBCC | EFIAE0129111 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141456
FDA Product Code
| PGW | Ear, Nose, And Throat Stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
[EFIAE0129111]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-30 |
| Device Publish Date | 2016-08-08 |
Devices Manufactured by Fiagon GmbH
| 04260759930010 - Navigation Sensor Flexarm | 2024-01-15 Field generating device, component of RIWOtrack Navigation System |
| 04260759930027 - Localizer K-Wire | 2024-01-15 Patient referencing device, component of RIWOtrack Navigation System |
| 04260759930034 - MapperBridge | 2024-01-15 Patient registration device, component of RIWOtrack Navigation System |
| 04260759930041 - MultiPad | 2024-01-15 Tool registration device, component of RIWOtrack Navigation System |
| 04260759930058 - RIWOtrack Cube4D | 2024-01-15 Navigation unit, Component of RIWOtrack Navigation System |
| 04260759930072 - Adapter for Flexsensor | 2024-01-15 Adapter for navigation probe, to be used with RIWOtrack Flexsensor, component of RIWOtrack Navigation System |
| 04260759930089 - Adapter for Clipsensor | 2024-01-15 Adapter for navigation probe, to be used with RIWOtrack Clipsensor, component of RIWOtrack Navigation System |
| 04260759930096 - RIWOtrack Flexsensor | 2024-01-15 Navigation probe, component of RIWOtrack Navigation System |
Trademark Results [Guidewire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GUIDEWIRE 87540652 5401314 Live/Registered |
Guidewire Software, Inc. 2017-07-24 |
 GUIDEWIRE 78662211 3185991 Live/Registered |
Guidewire Software, Inc. 2005-06-30 |
 GUIDEWIRE 77016329 3273576 Dead/Cancelled |
Yu, Steven S. 2006-10-07 |
 GUIDEWIRE 76474094 not registered Dead/Abandoned |
GUIDEWIRE SYSTEMS, INC. 2002-12-12 |
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