| Primary Device ID | B915015700401 |
| NIH Device Record Key | 9192693a-9127-4f1c-be27-13fc820001e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARCUSdigma 3 |
| Version Model Number | 01570040 |
| 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 | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com | |
| Phone | +49735156270 |
| service.multimedia@kavokerr.com |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B915015700401 [Primary] |
| NFS | Device, Jaw Tracking, For Monitoring Jaw Positions |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
[B915015700401]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-26 |
| Device Publish Date | 2021-02-18 |
| B915015700401 | Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and |
| B915011700400 | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. |