DABRA Laser System

GUDID 00842362100024

A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite dimers (typically rare gas monohalides such as argon fluoride, xenon chloride) as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation (UVA and/or UVB) for endovascular therapy. It typically includes a light source, delivery catheter, and controls/foot-switch. It is typically intended to treat endovascular disease.

RA MEDICAL SYSTEMS, INC.

Atherectomy excimer laser system

• Primary Device ID: 00842362100024
• NIH Device Record Key: 6c63ea01-11e9-4360-83e5-838e42d74bbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DABRA Laser System
• Version Model Number: RA-308
• Company DUNS: 131845013
• Company Name: RA MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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
GS1	00842362100024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170349

FDA Product Code

• PDU: Catheter For Crossing Total Occlusions

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-13

Devices Manufactured by RA MEDICAL SYSTEMS, INC.

• 00842362100017 - Pharos: 2019-02-07 A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input
• 00842362100024 - DABRA Laser System: 2018-07-06A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite dimers (typically rare gas monohalides such as argon fluoride, xenon chloride) as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation (UVA and/or UVB) for endovascular therapy. It typically includes a light source, delivery catheter, and controls/foot-switch. It is typically intended to treat endovascular disease.
• 00842362100024 - DABRA Laser System: 2018-07-06 A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input
• 00842362100031 - DABRA 101 Catheter: 2018-07-06 Percutaneous Catheter