Visica 2 VS3000

GUDID 00868390000211

The Visica 2 Treatment System is a cryosurgical system consisting of a control unit that controls one single use disposable probe. The system utilizes a cryogen, liquid nitrogen, as a cooling agent and a resistance heater for thawing. The Visica 2 Console is a self contained, mobile unit featuring an easy to use touch screen interface for complete control and monitoring of the cryoablation procedure. The touch screen allow users to select treatment modes, times, and cycles.

SANARUS TECHNOLOGIES, INC.

General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic
Primary Device ID00868390000211
NIH Device Record Key337272b5-a125-4709-929c-8d420781ee29
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisica 2
Version Model NumberVS3000
Catalog NumberVS3000
Company DUNS831350785
Company NameSANARUS TECHNOLOGIES, INC.
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

Customer Support Contacts

Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com
Phone800-909-3060
Emailsupport@sanarus.com

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1013 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1013 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100868390000211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

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 Date2016-09-06

Devices Manufactured by SANARUS TECHNOLOGIES, INC.

00868390000204 - V2 ICE Probe SL2018-07-06 The V2 ICE Probe SL (2.4 mm) is a single use, disposable probe designed for use with the Visica 2 Treatment System. The primary
00868390000211 - Visica 22018-07-06The Visica 2 Treatment System is a cryosurgical system consisting of a control unit that controls one single use disposable probe. The system utilizes a cryogen, liquid nitrogen, as a cooling agent and a resistance heater for thawing. The Visica 2 Console is a self contained, mobile unit featuring an easy to use touch screen interface for complete control and monitoring of the cryoablation procedure. The touch screen allow users to select treatment modes, times, and cycles.
00868390000211 - Visica 22018-07-06 The Visica 2 Treatment System is a cryosurgical system consisting of a control unit that controls one single use disposable prob
00868390000228 - V2 ICE PROBE2018-07-06 The V2 ICE Probe is a single use, disposable probe designed for use with the Visica 2 Treatment System. The primary components

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