Thuvera

GUDID 00810071230134

Thuvera Wired Footswitch

IPG Medical Corporation

General/multiple surgical solid-state laser system

• Primary Device ID: 00810071230134
• NIH Device Record Key: 6ae17132-0e98-4575-b8d8-8757c3c86ca7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thuvera
• Version Model Number: MD2300F-001952
• Company DUNS: 081504133
• Company Name: IPG Medical Corporation
• 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: 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810071230134 [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: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [Thuvera]

• 00810071230820: Thuvera Thulium Fiber Laser System
• 00810071230226: Thuvera Laser Console
• 00810071230134: Thuvera Wired Footswitch
• 00810071230066: Thuvera, Flat Tip, Single-Use Laser Fiber, 940um
• 00810071230059: Thuvera, Flat Tip, Single-Use Laser Fiber, 550um
• 00810071230042: Thuvera, Flat Tip, Single-Use Laser Fiber, 365um
• 00810071230035: Thuvera, Flat Tip, Single-Use Laser Fiber, 200um
• 00810071230028: Thuvera, Flat Tip, Single-Use Laser Fiber, 150um
• 00810071230011: Thuvera, Ball Tip, Single-Use Laser Fiber, 200um
• 00810071230004: Thuvera, Ball Tip, Single-Use Laser Fiber, 150um
• 00810071230141: Thuvera Wireless Footswitch
• 00810071230851: Thuvera Thulium Fiber Laser System - Eval
• 00810071230844: Thuvera Thulium Fiber Laser System - Hospital Owned
• 00810071230837: Thuvera Thulium Fiber Laser System - Repair
• 00810071230110: Thuvera, Flat Tip, Reusable Laser Fiber, 940um
• 00810071230103: Thuvera, Flat Tip, Reusable Laser Fiber, 550um
• 00810071230097: Thuvera, Flat Tip, Single-Use Laser Fiber, 365um
• 00810071230080: Thuvera, Flat Tip, Reusable Laser Fiber, 200um
• 00810071230073: Thuvera, Flat Tip, Reusable Laser Fiber, 150um