| Primary Device ID | 00850019946086 |
| NIH Device Record Key | 72dec08c-fead-477d-b004-35baf642bc58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Standard Imaging MAX 4000 Plus Electrometer |
| Version Model Number | 90020 |
| Catalog Number | 90020 |
| Company DUNS | 788084705 |
| Company Name | STANDARD IMAGING INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 00850019946086 [Primary] |
| LHO | Instrument, Quality-Assurance, Radiologic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-30 |
| Device Publish Date | 2023-06-22 |
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