| Primary Device ID | 00840682110815 |
| NIH Device Record Key | a94e358e-a194-4f41-b833-b6ad003823cc |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | L8-18i-RS |
| Company DUNS | 696021596 |
| Company Name | GE HEALTHCARE JAPAN CORPORATION |
| 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 |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682110815 [Primary] |
| IYO | System, imaging, pulsed echo, ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-15 |
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| 00195278718204 - Revolution | 2024-05-03 Ascend Select Gantry common top asm with UDI |
| 00195278620453 - DLIR | 2023-07-10 SWMD DLIR Application for Smart Subscription |
| 00195278303196 - ASiR-V | 2021-09-02 ASiR-V Application Container for Smart Subscription |
| 00195278303202 - DLIR | 2021-09-02 DLIR Application Container for Smart Subscription |
| 00195278303219 - MAR | 2021-09-02 MAR Application Container for Smart Subscription |
| 00840682146173 - Revolution | 2020-12-04 NGX Gantry common top asm with UDI |