WEDGE, 5" x 5" x 15" Medical Device Identification

GUDID 00810050244794

WEDGE, 5" x 5" x 15"

DOMICO MED-DEVICE, LLC

Multifunction body cushion

Primary Device ID	00810050244794
NIH Device Record Key	cf37c56c-efc1-4829-a63e-0403004100cf
Commercial Distribution Status	In Commercial Distribution
Version Model Number	108
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

Device Dimensions

Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch
Height	5 Inch
Width	5 Inch
Length	15 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050244794 [Primary]

FDA Product Code

KXJ	Table, Radiologic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-10-15
Device Publish Date	2021-10-07

Devices Manufactured by DOMICO MED-DEVICE, LLC

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�