| Primary Device ID | 10810050245446 |
| NIH Device Record Key | bb644483-ac99-4ece-a53c-ca3b8961ac98 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6000 |
| 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 | 00810050245449 [Primary] |
| GS1 | 10810050245446 [Package] Contains: 00810050245449 Package: [50 Units] In Commercial Distribution |
| BWN | Table And Attachments, Operating-Room |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
[10810050245446]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-23 |
| Device Publish Date | 2023-10-13 |
| 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 | 2023-10-23Cord Management Drape |
| 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 |