GUDID 00810050244596

ACCESSORY KIT, CARTESION PRIME. Includes: 9006 - STRAP, CHIN (00810050242103), 9007 - STRAP, FOREHEAD W/ADULT PAD (00810050242134), 9008 - KIT, ADULT HEAD REST (00810050243209), 9009 - WEDGE, TILT (00810050242431), 9017 - WEDGE, KNEE, 10.7” x 21.88” x 18.33” (00810050242424), 9020F - PAD, PEDIATRIC POSITIONING (00810050241441), 9025 - HOLDER, CORONAL HEAD (00810050241229), 9061 – STRAP, WIDE SECURITY, 14.17” x 21.12” (20810050242909), 9062 - STRAP, NARROW SECURITY FOR THE SHIELD (20810050242886), 9080 - SLIDE RAIL, DETACHABLE, AQULION ONE (10810050242841), 9092 - PAD, AQUILION ONE ADULT HOLDER (00810050241380), 9093 - PAD, AQUILION ONE CHILD HOLDER (00810050241397), 9094 - PAD, AQUILION ONE PEDIATRIC HOLDER (00810050242448), 9095 - PAD, AQUILION ONE WEDGE (00810050241403), 9096 - WEDGE, TAPER, 1.5” x 3.5” x 3” (10810050243008), 9097 - STRAP, VELTEX, 2” x 22” (10810050242896), 9112 - COVER, PROTECTIVE, FOOT EXTENSION PAD (10810050242674), 9113 - STRAP, WIDE BARIATRIC EXTENDER 30" (00810050242172), 9114 - STRAP, NARROW BARIATRIC EXTENDER 30" (00810050242158), 9121 – TABLE PAD COVER (00861001002659), 9122 – TABLE PAD, CARTESION PRIME (00810050244572), 9123 – FOOT PAD, CARTESION PRIME (00810050244589)

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

• Primary Device ID: 00810050244596
• NIH Device Record Key: 8c7c9c9c-d504-4824-8632-d82a475ddf21
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 9124
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00810050244596 [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: 2021-08-30
• Device Publish Date: 2021-08-20

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"