N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00810050243384
• Version / Model: 33254
• Company Name: DOMICO MED-DEVICE, LLC
• Labeler DUNS: 081253414
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 1
• Public Version Date: 2020-10-02
• Public Version Status: New
• Public Device Record Key: 53a751ac-0887-4c5a-a617-05b36290bbf1

Device Description

POSITIONING KIT. Includes: 110 - WEDGE, 3” x 3” x 7.25” (10810050242957), 111 - WEDGE, 6.75” x 6.75” x 7.25” (00810050242332), 112 - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050241175), 113 - WEDGE, 2.25” x 9.5” x 7.25” (10810050242926), 114 - RECTANGLE, 2” x 7.5” x 9.5” (00810050241649), 151 - BLOCK, DECUBITUS, 4” x 18” x 24” (00810050240277), 153 - CYLINDER, 4.25” DIAMETER x 12” (00810050240406), 154 - MATTRESS, THIN, .25” x 18” x 24” (00810050240512), 171 - PAD, TABLE, 1” x 24” x 72” (00810050240420)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXJ	Table, Radiologic	Radiology	892.1980	2
CCX	Support, Patient Position	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41058	Multifunction body cushion	A soft pillow or pad designed to provide support and comfort to a user's body part(s) in a variety of locations and positions, or to assist the user to fulfill a functional requirement involving various body parts. The device can be designed in a number of configurations that include a combined armrest-back support device, or an adjustable device.	No	Active
61131	Radiological general body-part positioner	A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810050243384	GS1