Trimedyne® 2120 OmniPulse Mini™ Holmium Laser System 2120

GUDID M47321200

Model 2120 - OmniPulse Mini Holmium Laser System

TRIMEDYNE, INC.

General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system

• Primary Device ID: M47321200
• NIH Device Record Key: 18e8f38f-68bf-4730-9316-eed80d7396d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trimedyne® 2120 OmniPulse Mini™ Holmium Laser System
• Version Model Number: 2120
• Catalog Number: 2120
• Company DUNS: 057007239
• Company Name: TRIMEDYNE, INC.
• Device Count: 1
• DM Exempt: false
• 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

Customer Support Contacts

• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com
• Phone: 8007335273
• Email: customerservice@trimedyne.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M47321200 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2023-06-22
• Device Publish Date: 2023-06-14

Devices Manufactured by TRIMEDYNE, INC.

• M47321200 - Trimedyne® 2120 OmniPulse Mini™ Holmium Laser System: 2023-06-22Model 2120 - OmniPulse Mini Holmium Laser System
• M47321200 - Trimedyne® 2120 OmniPulse Mini™ Holmium Laser System: 2023-06-22 Model 2120 - OmniPulse Mini Holmium Laser System
• M47312100 - Trimedyne® 1210 OmniPulse™ Holmium Laser System: 2020-02-27 Model 1210 - OmniPulse Holmium Laser System
• M4731210VHP0 - Trimedyne® 1210-VHP OmniPulse Max™ Holmium Laser System: 2020-02-27 Model 1210-VHP - OmniPulse Max Holmium Laser System
• M4731210VHPA0 - Trimedyne® 1210-VHPA OmniPulse Max™ Holmium Laser System: 2020-02-27 Model 1210-VHPA - OmniPulse Max Holmium Laser System
• M4731230300 - Trimedyne® 1230-30 OmniPulse Jr.™ Holmium Laser System: 2020-02-27 Model 1230-30 - OmniPulse Jr. Holmium Laser System
• M4731500A0 - Trimedyne® Model 1500-A Holmium Laser System: 2020-02-27 Model 1500-A - Holmium Laser System
• M47320021M0 - Trimedyne® FlexMax® 550 µm Reusable Holmium Bare Fiber: 2020-02-27 Fiber, Bare, 550um, Reusable, TMED Connector
• M47320021MSMA0 - Trimedyne® FlexMax® 550 µm Reusable Holmium Bare Fiber (SMA Connector): 2020-02-27 Fiber, Bare, 550um, Reusable, SMA Connector