| Primary Device ID | 16977943360076 |
| NIH Device Record Key | be61452b-dff7-4ad7-a980-25efc24c7894 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medical CT X-ray tube assembly |
| Version Model Number | ZS502L/H580C |
| Company DUNS | 984283061 |
| Company Name | Beijing Smartbeam Medical Devices Co.,LTD |
| 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 | true |
| 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 | 16977943360076 [Primary] |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-23 |
| Device Publish Date | 2024-12-13 |
| 16977943360144 | ZS802L/H560A |
| 16977943360137 | ZS802B/H601A |
| 16977943360120 | ZS752B/H425A |
| 16977943360113 | ZS712L/H485B |
| 16977943360106 | ZS702L/H847B |
| 16977943360090 | ZS632B/H847A |
| 16977943360083 | ZS602L/H560B |
| 16977943360076 | ZS502L/H580C |
| 16977943360069 | ZS502L/H580A |
| 16977943360052 | ZS502B/H590A |
| 16977943360045 | ZS402L/H493A |
| 16977943360038 | ZS352C/H485A |
| 16977943360021 | ZS352B/H498A |
| 16977943360014 | ZS302B/H580B |