WEDGE, 14" x 28" x 16" Medical Device Identification

GUDID 00810050244633

WEDGE, 14" x 28" x 16"

DOMICO MED-DEVICE, LLC

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Primary Device ID	00810050244633
NIH Device Record Key	69d8d990-5423-46f7-befc-d61c7d834219
Commercial Distribution Status	In Commercial Distribution
Version Model Number	195-8
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	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch
Height	14 Inch
Width	28 Inch
Length	16 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050244633 [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	2021-09-01
Device Publish Date	2021-08-24

Devices Manufactured by DOMICO MED-DEVICE, LLC

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�
00810050240840 - NA	2023-02-22 WEDGE, 4" x 11" x 7", SET OF 2
00810050243148 - NA	2023-02-22 WEDGE, 3" x 10" x 10"