| Primary Device ID | 00858340006431 |
| NIH Device Record Key | ba657907-4b69-40e4-8f86-0818216e20b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | D-EVO Suite FSx |
| Version Model Number | FM-FMT18M |
| Company DUNS | 078671236 |
| Company Name | Del Medical, Inc. |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858340006431 [Primary] |
| KPR | System, X-Ray, Stationary |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-26 |
| Device Publish Date | 2024-03-18 |
| 00858340006431 | The FM-FMT18M is the version of the D-EVO Suite FSx system which uses a floor mounted tube stand |
| 00858340006424 | The FM-FMT18T is the version of the D-EVO Suite FSx system which uses a floor mounted tube stand |
| 00858340006417 | The FM-OTC18M is the version of the D-EVO Suite FSx system which uses an overhead tube crane and |
| 00858340006400 | The FM-OTC18T is the version of the D-EVO Suite FSx system which uses an overhead tube crane and |