Fibernex Laser System

GUDID 10810050855782

Fibernex Go Laser System

TYPENEX MEDICAL LLC

General/multiple surgical diode laser system

• Primary Device ID: 10810050855782
• NIH Device Record Key: 3c0ecfbe-bece-4764-bd31-9ddf0c381041
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fibernex Laser System
• Version Model Number: LS0201
• Company DUNS: 600850213
• Company Name: TYPENEX MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050855785 [Primary]
GS1	10810050855782 [Package]; Contains: 00810050855785; Package: Case [1 Units]; In Commercial Distribution

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: 2025-08-05
• Device Publish Date: 2025-07-28

Devices Manufactured by TYPENEX MEDICAL LLC

• 20810050855833 - Microscope Slides: 2026-03-31 Liquid Based Cytology Slides, Uncoated, Single Circle on Front, Ground Edge, 45° Corners, Blue (LC0105B)
• B050SL1000021 - Sterile Labels: 2026-03-25 Sterile Label Kit: 1 - 10 UP Custom Printed Label Sheet 1 - Utility Marker
• 00810050855815 - ThermoFlo®: 2026-02-03 ThermoFlo Heat and Moisture Exchanger, Elbow
• 10810050855805 - Typenex Introducer Set: 2025-11-25 Micro Introducer: 4F x 20cm, Smooth Tip Needle, 0.018 Nitinol/AU Wire, Stiffen Dilator
• 10810050855782 - Fibernex Laser System: 2025-08-05Fibernex Go Laser System
• 10810050855782 - Fibernex Laser System: 2025-08-05 Fibernex Go Laser System
• 20810050855772 - Microscope Slides: 2025-07-22 Liquid Based Cytology Slides, Uncoated, Single Circle, Ground Edge, 45° Corners, Blue (LC0104B)
• 20810050855765 - Microscope Slides: 2025-07-16 Premium Microscope Slide, Ground Edges, 45° Corners, White (PS0204W)
• 20810050855741 - Microscope Slides: 2025-06-25 Premium Microscope Slide, Positive Charged, Thermal Printing, Ground Edges, 45° Corners - White Frosted (PS0404WXT)