Sun Nuclear MICRO+ MR

FDA UDI

Class I (US FDA UDI)

by Sun Nuclear Corp.

Identity

Trade Name: Sun Nuclear MICRO+ MR FDA UDI
Generic Name: Laser patient positioning system FDA UDI
Device Name: The MICRO+ MR MLR+350 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. FDA UDI
Model / Reference: MLR+350MR FDA UDI
Description: The MICRO+ MR MLR+350 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. FDA UDI

Identifiers

Catalog Number: 805876 FDA UDI
Primary DI / UDI-DI: B136MLR350MR0 FDA UDI
FDA Product Code: IWE FDA UDI
GMDN Term: Laser patient positioning system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.5780 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Laser patient positioning system

Sun Nuclear MICRO+ MR by Sun Nuclear Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Sun Nuclear Corp.

Sources (1)

FDA UDI cb0e7f25-9df1-4c3f-84ea-d37f5f60de3d 34 fields · synced Jun 8, 2026