| Primary Device ID | 00840682106139 |
| NIH Device Record Key | 1008eec9-b237-42c1-bb48-d3b48af5f0ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WIRELESS DR IMAGING OPTION |
| Version Model Number | WDR1 |
| Company DUNS | 654659689 |
| Company Name | Hangwei GE 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 | 00840682106139 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-01 |
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| 00195278526892 - Definium | 2023-09-26 Definium Pace Select system designated medical device |
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| 00195278713766 - NA | 2023-09-26 Value Fixed Table |
| 00195278686718 - Revolution | 2023-06-30 Revolution Maxima CT designated medical device |