Posifix® Headrest

Basic Information

• Brand Name: Posifix® Headrest
• Primary DI: 00841439100967
• Version / Model: 301026
• Catalog Number: 301026
• 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: 2020-03-31
• Public Version Status: Update
• Public Device Record Key: 9e84abd4-8e93-4f74-9f5c-07b30ee4e52a

Device Description

Posifix® Headrest - Supine (Pediatric)

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
LNH	System, nuclear magnetic resonance imaging	Radiology	892.1000	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	00841439100967	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060737	000
K093738	000