NA

Basic Information

• Brand Name: NA
• Primary DI: 00810050245128
• Version / Model: 8-UF
• Company Name: DOMICO MED-DEVICE, LLC
• Labeler DUNS: 081253414
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-18
• Public Version: 2
• Public Version Date: 2023-02-22
• Public Version Status: Update
• Public Device Record Key: 1039d50e-657e-4c2f-ac4a-af7f88422b45
• Distribution End Date: 2023-02-17

Device Description

KIT, SMALL "E". Includes: 101-UF - BLOCK, BASALAR, 7” x 16” x 12” (00810050244954), 102-UF - HOLDER, ADULT AP-PA HEAD (00810050244107), 104-UF - BLOCK, PRESSURE, 5.5” x 7.38” x 10” (00810050244466), 128-UF – WEDGE, 3” x 10” x 10” (00810050243148), 129-UF – WEDGE, 4.63" x 10" x 10" (00810050240864), 130-UF – WEDGE, 10" x 10" x 10" (00810050243155), 131-UF – RECTANGLE, 4” x 10” x 10” (00810050244442), 136-UF – WEDGE, 2.25” x 8” x 10” (00810050243117), 138-UF – WEDGE, 3.75” x 8” x 10” (00810050244152), 140-UF – WEDGE, 6" x 10" x 10" (00810050243162)

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
IWY	Holder, Head, Radiographic	Radiology	892.1920	1
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
61132	Radiological headrest	A non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810050245128	GS1