Aura XP

GUDID 00878953001692

Laser System

AMERICAN MEDICAL SYSTEMS

General/multiple surgical frequency-doubled solid-state laser system
Primary Device ID00878953001692
NIH Device Record Key923d31f8-79a4-427e-9a87-8f91777013ad
Commercial Distribution Discontinuation2019-01-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAura XP
Version Model Number0010-8118R
Company DUNS796308653
Company NameAMERICAN MEDICAL SYSTEMS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100878953001692 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-13
Device Publish Date2016-09-24

On-Brand Devices [Aura XP]

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

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