| Primary Device ID | B915015700721 |
| NIH Device Record Key | 4192e52f-06aa-4634-8f37-34d95f9fbfb9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PlaneAnalyser II USB |
| Version Model Number | 01570072 |
| Company DUNS | 328971791 |
| Company Name | zebris MEDICAL GmbH |
| 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 | true |
| 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 | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com | |
| Phone | +1 800 699 1813 |
| supportUSA@zirkonzahn.com |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B915015700721 [Primary] |
| NFS | Device, Jaw Tracking, For Monitoring Jaw Positions |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
[B915015700721]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-28 |
| Device Publish Date | 2023-07-20 |
| B915015700721 | Opto-Electronic System including Face-Bow for monitoring and tracking of lower jaw movements and |
| B915011700720 | Opto-Electronic Face-Bow for monitoring and tracking of lower jaw movements, USB-Version |