CoolTouch EZ Pass 400

GUDID 00859932006075

Fiber Optic Catheter

NEW STAR LASERS, 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 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: 00859932006075
• NIH Device Record Key: 2aec36b2-f5c0-4fe2-baee-976ca3f0627a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoolTouch EZ Pass 400
• Version Model Number: 7420-0087
• Company DUNS: 877266163
• Company Name: NEW STAR LASERS, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00859932006075 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-20

Devices Manufactured by NEW STAR LASERS, INC.

• 00859932006013 - StoneLight 15: 2018-07-06 Ho:YAG Laser System
• 00859932006211 - New Star Lasers: 2018-07-06 Fiber Optic Catheter
• 00859932006228 - New Star Lasers: 2018-07-06 Fiber Optic Catheter
• 00859932006235 - New Star Lasers: 2018-07-06 Fiber Optic Catheter
• 00859932006242 - New Star Lasers: 2018-07-06 Fiber Optic Catheter
• 00859932006006 - StoneLight 30: 2018-03-29 Ho:YAG Laser System
• 00859932006020 - CoolTouch CTEV: 2018-03-29 Nd:YAG Laser System
• 00859932006037 - CoolTouch ReNew: 2018-03-29 Nd:YAG Laser System