HIT Laser

Basic Information

• Brand Name: HIT Laser
• Primary DI: 17350005280106
• Version / Model: HITMX Red
• Company Name: C-Rad Positioning AB
• Labeler DUNS: 509296997
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-16
• Public Version: 1
• Public Version Date: 2020-07-24
• Public Version Status: New
• Public Device Record Key: bb299332-5375-4e2d-9d09-a4d081c7d5b7

Device Description

Laser Box Product Number: HW002 laser Product number: HW049

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: 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
IWE	Monitor, Patient Position, Light-Beam	Radiology	892.5780	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40893	Laser patient positioning system	A fixed or variable focal distance lasing device assembly designed to project a harmless beam (light pattern) onto a patient's skin or other alignment device. It is typically used to position and/or monitor the position of a patient during diagnostic imaging, radiation therapy, or radiation therapy treatment planning or simulation procedures. A set of these assemblies is used to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient's anatomy with respect to a radiation beam(s) used during diagnostic or therapeutic procedures. It typically includes a light source, mechanical/electronic controls, and associated mounting devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17350005280106	GS1

Customer Contacts

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