GUDID 00810050240895

CYLINDER, 4.25" DIAMETER x 12"

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

• Primary Device ID: 00810050240895
• NIH Device Record Key: d0885042-f808-4b11-a305-f1a78da72bf6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 153-UF
• 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

• Outer Diameter: 4.25 Inch
• Length: 12 Inch
• Outer Diameter: 4.25 Inch
• Length: 12 Inch
• Outer Diameter: 4.25 Inch
• Length: 12 Inch
• Outer Diameter: 4.25 Inch
• Length: 12 Inch
• Outer Diameter: 4.25 Inch
• Length: 12 Inch
• Outer Diameter: 4.25 Inch
• Length: 12 Inch
• Outer Diameter: 4.25 Inch
• Length: 12 Inch
• Outer Diameter: 4.25 Inch
• Length: 12 Inch
• Outer Diameter: 4.25 Inch
• Length: 12 Inch
• Outer Diameter: 4.25 Inch
• Length: 12 Inch
• Outer Diameter: 4.25 Inch
• Length: 12 Inch
• Outer Diameter: 4.25 Inch
• Length: 12 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050240895 [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: 2020-08-04
• Device Publish Date: 2020-07-27

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"