GUDID 00810050244855

40" ABDUCTOR ACCESSORY RAIL

DOMICO MED-DEVICE, LLC

Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner

• Primary Device ID: 00810050244855
• NIH Device Record Key: a45218d4-3da2-43ed-bbb9-56b5841ce3d7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 30465
• Company DUNS: 081253414
• Company Name: DOMICO MED-DEVICE, LLC
• Device Count: 2
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050244855 [Unit of Use]
GS1	10810050244852 [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

• 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"