| Primary Device ID | 00840682123730 |
| NIH Device Record Key | cdac6950-0298-4a0b-8ffe-ce8d10894938 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | O640 Upgrade |
| Version Model Number | H3100ZC |
| Company DUNS | 532102365 |
| Company Name | G E MEDICAL SYSTEMS ISRAEL 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 | true |
| 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 | 00840682123730 [Primary] |
| JAK | System, x-ray, tomography, computed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-08-16 |
| Device Publish Date | 2017-06-28 |
| 00195278755544 - StarGuide | 2024-04-26 StarGuide NM GANTRY MDR FINAL |
| 00195278794772 - D630 to D670 DR Upgrade | 2024-03-26 D630 to D670 DR NM GANTRY UPGRADE KIT |
| 00195278788252 - NM | 2023-11-23 830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE |
| 00195278788269 - NMCT | 2023-11-22 870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE |
| 00195278488619 - MyoSPECT | 2023-09-22 MyoSPECT MDR GANTRY |
| 00195278488626 - MyoSPECT ES | 2023-09-22 MyoSPECT ES MDR GANTRY |
| 00195278722546 - MyoSEPCT ES to MyoSPECT Upgrade | 2023-09-22 MyoSPECT ES to MyoSPECT Upgrade kit |
| 00195278592309 - Omni | 2022-09-20 OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY |