Primary Device ID | 00810050243148 |
NIH Device Record Key | 390aba89-97cd-4117-b18d-d16da19c7bef |
Commercial Distribution Discontinuation | 2023-02-17 |
Commercial Distribution Status | Not in Commercial Distribution |
Version Model Number | 128-UF |
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 |
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™ |
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 |