| Primary Device ID | B915015700201 |
| NIH Device Record Key | 39976b83-30cd-45b4-b1a5-1e050d7dcaa8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JMA Optic Schütz |
| Version Model Number | 01570020 |
| Catalog Number | NA |
| 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 | +4975629726300 |
| support@zebris.de | |
| Phone | +4975629726300 |
| support@zebris.de | |
| Phone | +4975629726300 |
| support@zebris.de | |
| Phone | +4975629726300 |
| support@zebris.de | |
| Phone | +4975629726300 |
| support@zebris.de | |
| Phone | +4975629726300 |
| support@zebris.de | |
| Phone | +4975629726300 |
| support@zebris.de | |
| Phone | +4975629726300 |
| support@zebris.de | |
| Phone | +4975629726300 |
| support@zebris.de | |
| Phone | +4975629726300 |
| support@zebris.de | |
| Phone | +4975629726300 |
| support@zebris.de | |
| Phone | +4975629726300 |
| support@zebris.de | |
| Phone | +4975629726300 |
| support@zebris.de | |
| Phone | +4975629726300 |
| support@zebris.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de | |
| Phone | +49600381444 |
| info@schuetz-dental.de |
| 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 |
| 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 | B915015700201 [Primary] |
| NFS | Device, Jaw Tracking, For Monitoring Jaw Positions |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
[B915015700201]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-27 |
| Device Publish Date | 2020-08-19 |
| B915015700201 | Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and |
| B915011700200 | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements |