| Primary Device ID | 60889971035738 |
| NIH Device Record Key | 333cbb49-226d-48f8-8940-5c8ee899227b |
| Commercial Distribution Discontinuation | 2018-12-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | CARESTREAM DRX-EVOLUTION |
| Version Model Number | CARESTREAM DRX-EVOLUTION |
| Catalog Number | 1035732 |
| Company DUNS | 793169512 |
| Company Name | CARESTREAM HEALTH, 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 60889971035738 [Primary] |
| IZO | Generator, high-voltage, x-ray, diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-12-12 |
| Device Publish Date | 2016-12-07 |
| 60889978001231 | DRX-EVOLUTION/P-PCSH-P-X W/WP |
| 60889978001194 | DRX-EVOLUTION/P-PCSH-P-X W/INWP |
| 60889978001170 | DRX-EVOLUTION/P-PCSH-P-X |
| 60889976565667 | ASSM-UNIVERSAL GRID HOLDER, DRX-EVOLUTIO |
| 60889976557655 | CARESTREAM DRX BABIX HOLDER |
| 60889976551523 | MOVEABLE TABLE FOR DR SYS |
| 60889971963789 | 80KW GENERATOR/FOR DRX-EVOLUTION |
| 60889971731678 | DRX-EVOLUTION/P-PCSH-P-X |
| 60889971731623 | DRX-EVOLUTION/B-BCSH-P-X |
| 60889971051301 | GRID/DRX-EVO WALL 140CM 8:1/40 LN/CM |
| 60889971035745 | DRX-EVO 80 kW GENERATOR STANDARD/Q |
| 60889971035738 | DRX-EVO 65 kW GENERATOR STANDARD/Q |