| Primary Device ID | 60889975950600 |
| NIH Device Record Key | 2246d2b8-1a5d-44a9-9cce-f55a1ae6ba07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Focus HD 35 Detector |
| Version Model Number | Focus HD 35 Detector |
| Catalog Number | AL4712 |
| 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 |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 60889975950600 [Primary] |
| MQB | Solid state x-ray imager (flat panel/digital imager) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-03 |
| Device Publish Date | 2023-06-24 |
| 60889976579336 - Vita Flex CR System | 2024-07-25 VITA FLEX CR SYSTEM 60PPH |
| 60889976579343 - Vita Flex CR System | 2024-07-25 VITA FLEX CR SYSTEM 60PPH WITH PC&MONITO |
| 60889976579367 - Vita Flex CR System | 2024-07-25 VITA FLEX CR SYSTEM, NB 60PPH WITH PC&MO |
| 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 |