Customizable Head Support

Basic Information

• Brand Name: Customizable Head Support
• Primary DI: 00841439102350
• Version / Model: CHS01
• Catalog Number: CHS01
• Company Name: MEDTEC, INC.
• Labeler DUNS: 103977526
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-02
• Public Version: 5
• Public Version Date: 2020-03-19
• Public Version Status: Update
• Public Device Record Key: 1ee61faa-d484-4c33-adf0-c3c2b06c556c

Device Description

Head support for Posifix® systems

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: No
• 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
IYE	Accelerator, linear, medical	Radiology	892.5050	2

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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841439102350	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K080072	000
K982624	000

Device Sizes

Type	Value	Unit	Text
Width	7.2	Inch
Length	10.5	Inch