Sun Nuclear MICRO

Basic Information

• Brand Name: Sun Nuclear MICRO
• Primary DI: B136MLR2000
• Version / Model: MLR 200
• Catalog Number: 805705
• Company Name: SUN NUCLEAR CORP.
• Labeler DUNS: 122240021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-25
• Public Version: 2
• Public Version Date: 2023-01-09
• Public Version Status: Update
• Public Device Record Key: 59bc8b30-ffbe-47f7-97d0-02368b978737

Device Description

The MICRO MLR 200 lasers are intended to be used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. The micro lasers are intended to be used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.

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 Unsafe
• 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	B136MLR2000	HIBCC