SPECTRA

GUDID 8809447650432

SPECTRA SL body U120V (SPECTRA laser system)

Lutronic Corporation

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

• Primary Device ID: 8809447650432
• NIH Device Record Key: 8d22f1f4-ddc3-4ea3-b10c-e8e814074b08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPECTRA
• Version Model Number: SPECTRA SL body U120V
• Company DUNS: 688282516
• Company Name: Lutronic 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: 215-205-2219
• Email: jvojir@lutronic.com
• Phone: 215-205-2219
• Email: jvojir@lutronic.com
• Phone: 215-205-2219
• Email: jvojir@lutronic.com
• Phone: 215-205-2219
• Email: jvojir@lutronic.com
• Phone: 215-205-2219
• Email: jvojir@lutronic.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809447650272 [Primary]
GS1	8809447650432 [Package]; Contains: 08809447650272; Package: Wooden box [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-26
• Device Publish Date: 2016-07-27

On-Brand Devices [SPECTRA]

• 8809447650432: SPECTRA SL body U120V (SPECTRA laser system)
• 08809447650265: Spectra-Option body U120V (SPECTRA laser system)