| Primary Device ID | B915015700521 |
| NIH Device Record Key | 6cb50063-16b2-4c2c-8061-57addb3ee2b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | zebris for ceramill USB-L |
| Version Model Number | 01570052 |
| 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 | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.com | |
| Phone | +4972319573400 |
| ts@amanngirrbach.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 | B915015700521 [Primary] |
| NFS | Device, Jaw Tracking, For Monitoring Jaw Positions |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
[B915015700521]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-01 |
| Device Publish Date | 2023-07-24 |
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