UltravisionTM DAD-001-010

GUDID 05060417680023

UltravisionTM Visual Field Clearing System

ALESI SURGICAL LIMITED

Surgical fluid/smoke waste management system
Primary Device ID05060417680023
NIH Device Record Key41308e68-f0df-4509-a86e-d0c8326ee3f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltravisionTM
Version Model NumberUltravisionTM Generator
Catalog NumberDAD-001-010
Company DUNS219516254
Company NameALESI SURGICAL LIMITED
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060417680023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PQMSurgical Smoke Precipitator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-12

On-Brand Devices [UltravisionTM]

05060417680245UltravisionTM Visual Field Clearing System
05060417680214Ultravision Visual Field Clearing System
25060417680201Ultravision Visual Field Clearing System
05060417680139UltravisionTM Visual Field Clearing System
05060417680122UltravisionTM Visual Field Clearing System
05060417680061UltravisionTM Visual Field Clearing System
05060417680054UltravisionTM Visual Field Clearing System
05060417680177UltravisionTM Visual Field Clearing System
05060417680023UltravisionTM Visual Field Clearing System
05060417680016UltravisionTM Visual Field Clearing System
05060417680009UltravisionTM Visual Field Clearing System

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