| Primary Device ID | 60889971044297 |
| NIH Device Record Key | 4fa8b618-7c2d-4154-9502-a73a7e1c8c04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen |
| Version Model Number | DIRECTVIEW CR Mammography Cassette with EHR-M3 Scr |
| Catalog Number | 1044296 |
| Company DUNS | 793169512 |
| Company Name | CARESTREAM HEALTH, INC. |
| 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 | true |
| Serial Number | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 60889971044297 [Primary] |
| MUE | Full field digital, system, x-ray, mammographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-14 |
| Device Publish Date | 2021-06-06 |
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