GUDID 00810050240840

WEDGE, 4" x 11" x 7", SET OF 2

DOMICO MED-DEVICE, LLC

Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion Multifunction body cushion
Primary Device ID00810050240840
NIH Device Record Key9d9698c0-0597-4331-ac34-f879a821b64e
Commercial Distribution Discontinuation2023-02-17
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number159
Company DUNS081253414
Company NameDOMICO MED-DEVICE, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Dimensions

Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch
Height4 Inch
Width11 Inch
Length7 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100810050240840 [Primary]

FDA Product Code

KXJTable, Radiologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-02-22
Device Publish Date2020-06-11

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 - NA2023-10-23 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 - NA2023-02-22WEDGE, 4" x 11" x 7", SET OF 2
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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