| Primary Device ID | 00195278011022 | 
| NIH Device Record Key | af1d6d22-b490-40e7-bf31-2ebb68e51754 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Version Model Number | 5842636 | 
| Company DUNS | 654659689 | 
| Company Name | Hangwei GE Medical Systems Co., Ltd. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | MR Conditional | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | false | 
| Serial Number | false | 
| 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 | 
| Phone | +1(999)999-9999 | 
| xx@xx.xx | |
| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
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| Phone | +1(999)999-9999 | 
| xx@xx.xx | |
| Phone | +1(999)999-9999 | 
| xx@xx.xx | |
| Phone | +1(999)999-9999 | 
| xx@xx.xx | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00195278011022 [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 | 2020-12-02 | 
| Device Publish Date | 2020-11-24 | 
| 00198953049631 - Revolution | 2025-09-17 Revolution Maxima CT designated medical device for India, without SGB Tube | 
| 00195278943934 - Revolution | 2025-09-01 Revolution Vibe - Designated System Medical Device | 
| 00195278907202 - Revolution | 2025-04-08 Revolution RT Gantry designated Medical Device, WSO | 
| 00195278923257 - Revolution | 2025-03-13 Revolution Maxima CT designated medical device | 
| 00195278940292 - Revolution | 2025-03-10 Revolution Maxima CT designated medical device, WSO make | 
| 00195278685001 - OEC | 2025-01-17 MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One ASD | 
| 00195278809810 - Revolution | 2025-01-03 Revolution RT Gantry designated Medical Device, GEHW | 
| 00195278913807 - Definium | 2024-11-07 Definium Pace Select ET System UDI |