| Primary Device ID | 60889971056504 |
| NIH Device Record Key | 4e8b1824-0521-4a14-b491-a9d535cbc814 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Max CR System |
| Version Model Number | Max CR System |
| Catalog Number | 1056506 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 60889971056504 [Primary] |
| MQB | Solid state x-ray imager (flat panel/digital imager) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 9 |
| Public Version Date | 2020-03-09 |
| Device Publish Date | 2016-09-16 |
| 60889978625925 - Carestream DRX-1 System | 2023-07-31 DRX-1 SYSTEM CONSOLE UPGRADE |
| 60889978624768 - DRX-Compass X-ray System | 2023-07-06 XRAY OTC 80KW 400KHU AUTOTILT CF OSHPD |
| 00889978626487 - D-Speed | 2023-07-04 100PKT FLASH D-SPEED PERFECT FLM SIZE2 |
| 60889978818891 - Ultra-speed | 2023-07-04 ULTRA-SPEED 150PKT 30.5X40.5 FILM DF58 L |
| 60889976554104 - CARESTREAM DR Long Length Imaging Stand | 2023-07-04 STEP STOOL FOR LLI |
| 60889975950600 - Focus HD 35 Detector | 2023-07-03 FOCUS HD 35 DETECTOR PACK ROK |
| 60889975950617 - Focus HD 43 Detector | 2023-07-03 FOCUS HD 43 DETECTOR PACK ROK |
| 60889978626007 - DRX-Rise Mobile X-ray System | 2023-06-30 DRX-RISE MOBILE X-RAY SYSTEM |