GUDID 00810050245494

Domico MRI Breast Positioning System™

DOMICO MED-DEVICE, LLC

Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner
Primary Device ID00810050245494
NIH Device Record Keydb9eee02-de68-44fd-8529-cfff2c6b388b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number282
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
GS100810050245494 [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 Date2023-10-23
Device Publish Date2023-10-13

Devices Manufactured by DOMICO MED-DEVICE, LLC

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 - NA2023-10-23Domico MRI Breast Positioning System™
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�
00810050240840 - NA2023-02-22 WEDGE, 4" x 11" x 7", SET OF 2
00810050243148 - NA2023-02-22 WEDGE, 3" x 10" x 10"

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