| Primary Device ID | 10810050245545 |
| NIH Device Record Key | 544a9e48-f36b-4fe1-a814-934c64d68328 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6001 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 00810050245548 [Primary] |
| GS1 | 10810050245545 [Package] Contains: 00810050245548 Package: [10 Units] In Commercial Distribution |
| NBH | Accessories, Arthroscopic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-08 |
| Device Publish Date | 2024-12-31 |
| 10810050245545 - NA | 2025-01-08BUFFING PAD |
| 10810050245545 - NA | 2025-01-08 BUFFING PAD |
| 10810050245552 - NA | 2025-01-08 Non-Sterile Buffing Pad |
| 00810050245524 - NA | 2024-07-01 The Shield, Aquilion ONE |
| 00810050245531 - NA | 2024-07-01 Aquilion ONE INSIGHT Kit. Includes: 9006 - STRAP, CHIN (00810050242103), 9007 - STRAP, FOREHEAD W/ADULT PAD (00810050242134), 90 |
| 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™ |