| Primary Device ID | 00810050245401 |
| NIH Device Record Key | e8b619e6-77f9-4fab-819b-dbbcf0fe64b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 33350 |
| Company DUNS | 081253414 |
| Company Name | DOMICO MED-DEVICE, LLC |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810050245401 [Primary] |
| FMR | Device, Transfer, Patient, Manual |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-08 |
| Device Publish Date | 2022-10-31 |
| 00810050245517 - NA | 2024-01-08 MRI BREAST POSITIONING SYSTEM - RMI |
| 00810050245500 - NA | 2023-11-08 KIT, SMALL, "A". Includes: 112-UF - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050240581), 114-UF - RECTANGLE, 2” x 7.5” x |
| 10810050245446 - NA | 2023-10-23 Cord Management Drape |
| 00810050245494 - NA | 2023-10-23 Domico MRI Breast Positioning System™ |
| 00810050245470 - NA | 2023-05-09 RECTANGLE, 3" x 7.50" x 10" |
| 00810050245487 - NA | 2023-05-09 KIT, LARGE. Includes: 100-UF - BLOCK, TORSO, 7” x 12” x 16” (00810050243605), 101-UF - BLOCK, BASALAR, 7” x 16” x 12� |
| 00810050240840 - NA | 2023-02-22 WEDGE, 4" x 11" x 7", SET OF 2 |
| 00810050243148 - NA | 2023-02-22 WEDGE, 3" x 10" x 10" |