CT HeadFix

Basic Information

• Brand Name: CT HeadFix
• Primary DI: 07640178060081
• Version / Model: CT HeadFix
• Catalog Number: 1105
• Company Name: Pearl Technology AG
• Labeler DUNS: 480151859
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-11
• Public Version: 1
• Public Version Date: 2022-05-19
• Public Version Status: New
• Public Device Record Key: 3197b4c6-0596-4d60-a5a8-4b18d8628b7b

Device Description

Positioning aid for head fixation in the CT head holder.

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: 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

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	07640178060081	GS1

Customer Contacts

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