| Primary Device ID | 00197644515615 |
| NIH Device Record Key | 4ffed343-ef59-46bc-bafe-8e94d37500e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Precision Cut EBT3 GafChromic(TM) Film |
| Version Model Number | 158200 |
| Catalog Number | 158200 |
| Company DUNS | 108245655 |
| Company Name | Computerized Imaging Reference Systems, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com | |
| Phone | (321) 259-6862 |
| globalsupport@sunnuclear.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00197644515615 [Primary] |
| 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 | 2023-09-04 |
| Device Publish Date | 2023-08-25 |
| 00197644515615 | Precision Cut EBT3 GafChromic(TM) Film |
| 00860011127406 | Precision Cut EBT3 GafChromic(TM) Film |