GUDID 00810050245517

MRI BREAST POSITIONING SYSTEM - RMI

DOMICO MED-DEVICE, LLC

Radiological whole-body positioner
Primary Device ID00810050245517
NIH Device Record Key58518755-160f-4db4-aa8b-345c49a1c8ba
Commercial Distribution StatusIn Commercial Distribution
Version Model Number33372
Company DUNS081253414
Company NameDOMICO MED-DEVICE, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810050245517 [Primary]

FDA Product Code

LWGSurgical Table Cushion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-08
Device Publish Date2023-12-29

Devices Manufactured by DOMICO MED-DEVICE, LLC

00810050245524 - NA2024-07-01 The Shield, Aquilion ONE
00810050245531 - NA2024-07-01 Aquilion ONE INSIGHT Kit. Includes: 9006 - STRAP, CHIN (00810050242103), 9007 - STRAP, FOREHEAD W/ADULT PAD (00810050242134), 90
00810050245517 - NA2024-01-08MRI BREAST POSITIONING SYSTEM - RMI
00810050245517 - NA2024-01-08 MRI BREAST POSITIONING SYSTEM - RMI
00810050245500 - NA2023-11-08 KIT, SMALL, "A". Includes: 112-UF - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050240581), 114-UF - RECTANGLE, 2” x 7.5” x
10810050245446 - NA2023-10-23 Cord Management Drape
00810050245494 - NA2023-10-23 Domico MRI Breast Positioning System™
00810050245470 - NA2023-05-09 RECTANGLE, 3" x 7.50" x 10"
00810050245487 - NA2023-05-09 KIT, LARGE. Includes: 100-UF - BLOCK, TORSO, 7” x 12” x 16” (00810050243605), 101-UF - BLOCK, BASALAR, 7” x 16” x 12

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