New Star Lasers

GUDID 00859932006242

Fiber Optic Catheter

NEW STAR LASERS, INC.

General/multiple surgical solid-state laser system

• Primary Device ID: 00859932006242
• NIH Device Record Key: a01235c7-6819-46fb-889c-66ab4c60d0bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: New Star Lasers
• Version Model Number: 7420-0060
• 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: false
• Lot Batch: true
• Serial Number: false
• 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	00859932006242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994273

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

[00859932006242]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [New Star Lasers]

• 00859932006242: Fiber Optic Catheter
• 00859932006235: Fiber Optic Catheter
• 00859932006228: Fiber Optic Catheter
• 00859932006211: Fiber Optic Catheter