Aura XP

GUDID 00878953001692

Laser System

AMERICAN MEDICAL SYSTEMS

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

• Primary Device ID: 00878953001692
• NIH Device Record Key: 923d31f8-79a4-427e-9a87-8f91777013ad
• Commercial Distribution Discontinuation: 2019-01-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aura XP
• Version Model Number: 0010-8118R
• Company DUNS: 796308653
• Company Name: AMERICAN MEDICAL SYSTEMS
• 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: 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	00878953001692 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-13
• Device Publish Date: 2016-09-24

On-Brand Devices [Aura XP]

• 00878953009377: US Power Cable
• 00878953009360: International Power Cable
• 00878953009353: Footswitch
• 00878953009087: Fiber Pole
• 00878953001708: Laser System
• 00878953001692: Laser System
• 00878953001685: Laser System
• 00878953001678: Laser System
• 00878953000220: Laser System