Sun Nuclear MICRO+

Primary DI
B136MLR3000
Brand
Sun Nuclear MICRO+
Company
SUN NUCLEAR CORP.
Model
MLR+300
Catalog number
805722
Device description
The MICRO+ MLR+300 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is 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.
Published
2021-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
IWEMonitor, Patient Position, Light-Beam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWEMonitor, Patient Position, Light-BeamRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B136MLR3000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laser patient positioning systemA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122240021
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840348505368AADCOAADCO MEDICAL, INC.IWE2022-12-12
00840348505375AADCOAADCO MEDICAL, INC.IWE2022-12-12
00840348505382AADCOAADCO MEDICAL, INC.IWE2022-12-12
00840348505399MRI-SafeAADCO MEDICAL, INC.IWE2022-12-12
00840348505405AADCOAADCO MEDICAL, INC.IWE2022-12-12
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00840348505429MRI-SafeAADCO MEDICAL, INC.IWE2022-12-12
00840348505436AADCOAADCO MEDICAL, INC.IWE2022-12-12
00840348505443AADCOAADCO MEDICAL, INC.IWE2022-12-12
00840348505450MRI-SafeAADCO MEDICAL, INC.IWE2022-12-12
00840348505467AADCOAADCO MEDICAL, INC.IWE2022-12-12
00840348505474AADCOAADCO MEDICAL, INC.IWE2022-12-12
00840348505498AADCOAADCO MEDICAL, INC.IWE2022-12-12
00840348505504AADCOAADCO MEDICAL, INC.IWE2022-12-12
00840348505788AADCOAADCO MEDICAL, INC.IWE2022-12-12
00840348502398HerculesAADCO MEDICAL, INC.IWE2022-12-09
00840348502404MRI-SafeAADCO MEDICAL, INC.IWE2022-12-09
00840348502411HerculesAADCO MEDICAL, INC.IWE2022-12-09
00840348502428HerculesAADCO MEDICAL, INC.IWE2022-12-09
00840348502435HerculesAADCO MEDICAL, INC.IWE2022-12-09
00840348502442MRI-SafeAADCO MEDICAL, INC.IWE2022-12-09
00840348502459HerculesAADCO MEDICAL, INC.IWE2022-12-09
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00840348502503HerculesAADCO MEDICAL, INC.IWE2022-12-09