| Primary Device ID | 60192155500114 |
| NIH Device Record Key | f381947a-753e-4a30-b192-0e6883760177 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CS 8100SC 3D |
| Version Model Number | CS 8100SC 3D |
| Catalog Number | 5500111 |
| Company DUNS | 019796106 |
| Company Name | CARESTREAM DENTAL LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 60192155500114 [Primary] |
| MUH | System,x-ray,extraoral source,digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-28 |
| Device Publish Date | 2018-01-15 |
| 60192155500114 | CS 8100SC 3D |
| 60192155942136 | CS 8100SC 3D Select |