Sun Nuclear MICRO 805709

GUDID B136MLB2000

The MICRO MLB 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.

GAMMEX, INC.

Laser patient positioning system

• Primary Device ID: B136MLB2000
• NIH Device Record Key: 786a19ff-5e90-4d20-bb29-4f712a2302bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sun Nuclear MICRO
• Version Model Number: MLB 200
• Catalog Number: 805709
• Company DUNS: 157308230
• Company Name: GAMMEX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B136MLB2000 [Primary]

FDA Product Code

• IWE: Monitor, Patient Position, Light-Beam

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-02
• Device Publish Date: 2021-01-25

On-Brand Devices [Sun Nuclear MICRO]

• B136MLR2000: The MICRO MLR 200 lasers are intended to be used for aligning patients to medical diagnostic ima
• B136MLR1500: The MICRO MLR 150 lasers are intended to be used for aligning patients to medical diagnostic ima
• B136MLG2000: The MICRO MLG 200 lasers are intended to be used for aligning patients to medical diagnostic ima
• B136MLG1500: The MICRO MLG 150 lasers are intended to be used for aligning patients to medical diagnostic ima
• B136MLB2000: The MICRO MLB 200 lasers are intended to be used for aligning patients to medical diagnostic ima
• B136MLB1500: The MICRO MLB 150 lasers are intended to be used for aligning patients to medical diagnostic ima