| Primary Device ID | 60889978156184 |
| NIH Device Record Key | ea5d2919-0eb1-4975-bc0e-4146ad757c97 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIRECTVIEW CR Mammography Cassette with EHR-M3 Scr |
| Version Model Number | DIRECTVIEW CR Mammography Cassette with EHR-M3 Scr |
| Catalog Number | 8156184 |
| 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 |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 40889978156180 [Primary] |
| GS1 | 60889978156184 [Package] Contains: 40889978156180 Package: Case [4 Units] In Commercial Distribution |
| MUE | Full field digital,system,x-ray,mammographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-16 |
| 60889978869848 | 24X30CM CR MAMMO SCR EHR-M3 |
| 60889978336197 | 18X24CM CR MAMMO SCR EHR-M3 |
| 60889978156184 | DIRECTVW CR Mammo Cass EHR-M3 Scrn 24x30 |
| 60889971790316 | DIRECTVW CR Mammo Cass EHR-M3 Scrn 18X24 |