| Primary Device ID | 10814905020882 |
| NIH Device Record Key | 3c19c66e-78ec-4e56-a7bc-67b4ecca8e3b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Codonics DirectVista Thermal Film, 1417-DVB5 |
| Version Model Number | 1417-DVB5 |
| Company DUNS | 101533727 |
| Company Name | CODONICS INC. |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 4402431334 |
| support@codonics.com |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814905020885 [Primary] |
| GS1 | 10814905020882 [Package] Contains: 00814905020885 Package: CASE [5 Units] In Commercial Distribution |
| IWZ | Film, Radiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-13 |
| Device Publish Date | 2020-02-05 |
| 00814905020915 | 1417-DVB5 Blue Base Film (100 sheet cassette) |
| 10814905020882 | 1417-DVB5 Blue Base Film (100 sheet box) |