MR/X-ray HFD (HFD 200)

Basic Information

• Brand Name: MR/X-ray HFD (HFD 200)
• Primary DI: 00857534006455
• Version / Model: 113010-600
• Company Name: IMRIS Imaging, Inc.
• Labeler DUNS: 079990922
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-04
• Public Version: 2
• Public Version Date: 2025-04-08
• Public Version Status: Update
• Public Device Record Key: 63c02269-bb59-4586-9e91-3029060098f4

Device Description

MR/X-ray Head Fixation Device (HFD 200)

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: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	882.4460	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35446	Skull clamp	A U-shaped surgical device intended to hold the head and neck in a particular fixed position during surgical procedures. It is connected to the skull with screws or pins (not included), typically on each side of the forehead, whilst the other end is fixed to an operating table or chair. Commonly known as a Mayfield skull clamp, it is made of metal materials (non-radiolucent) and may have adjustable joints (either incorporated or separate) for positioning/stabilization; it is not intended for applying traction forces to the cervical spine. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857534006455	GS1

Premarket Submissions

Submission Number	Supplement Number
K113748	000