N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00810050243490
• Version / Model: 9411
• 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: cb9d40c8-25bc-4853-bb13-580dc08ba867

Device Description

KIT, TOSHIBA INFINIX HEADHOLDER ACCESSORY. Includes: 9402 - INFINIX MANDIBULAR SUPPORT PADS (10810050242735), 9403 - INFINIX FOREHEAD PAD & STRAP (00810050243223), 9404 - INFINIX CHIN STRAP (00810050241311), 9405 - INFINIX NECK SUPPORT PADS (00810050243230), 9408 - INFINIX HEAD SUPPORT PAD (00810050241328)

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
IWY	Holder, Head, Radiographic	Radiology	892.1920	1
FMQ	Restraint, Protective	General Hospital	880.6760	1
CCX	Support, Patient Position	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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
62482	Limb/torso/head restraint, reusable	A non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.	No	Active
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810050243490	GS1