| Primary Device ID | 00198953023266 |
| NIH Device Record Key | ce1a8b7f-878f-4ba8-b935-f686eed48508 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | GCWS-C3 |
| Company DUNS | 554408665 |
| Company Name | GE Hualun Medical Systems Co., Ltd |
| 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 | true |
| 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 | 00198953023266 [Primary] |
| IXY | Holder, Radiographic Cassette, Wall-Mounted |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-10 |
| Device Publish Date | 2025-02-28 |
| 00195278913814 - Definium | 2025-09-15 Definium Tempo Select System UDI |
| 00195278901880 - NA | 2025-06-17 Gemini Tube Stand |
| 00198953043288 - NA | 2025-04-30 Gemini_Non-tilting_WS |
| 00198953043295 - NA | 2025-04-30 Gemini Tilting WS |
| 00198953043301 - NA | 2025-04-30 Radiographic Table |
| 00198953023259 - NA | 2025-03-10 G4 Non-Tilting Wallstand |
| 00198953023266 - NA | 2025-03-10G3A standard Wallstand |
| 00198953023266 - NA | 2025-03-10 G3A standard Wallstand |