GUDID 04250480101704

Camera Control Unit VP-7000X

SCHÖLLY FIBEROPTIC GmbH

Endoscope video camera
Primary Device ID04250480101704
NIH Device Record Keyf97a3f68-bf8e-4b25-afbd-12a0fdefb9f9
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberVP-7000X
Company DUNS316276682
Company NameSCHÖLLY FIBEROPTIC GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Customer Support Contacts

Phone9999999999
Emailinfo@schoelly-usa.com
Phone9999999999
Emailinfo@schoelly-usa.com
Phone9999999999
Emailinfo@schoelly-usa.com
Phone9999999999
Emailinfo@schoelly-usa.com
Phone9999999999
Emailinfo@schoelly-usa.com
Phone9999999999
Emailinfo@schoelly-usa.com
Phone9999999999
Emailinfo@schoelly-usa.com
Phone9999999999
Emailinfo@schoelly-usa.com
Phone9999999999
Emailinfo@schoelly-usa.com

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104250480101704 [Primary]

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-11
Device Publish Date2024-12-03

Devices Manufactured by SCHÖLLY FIBEROPTIC GmbH

04250480101704 - NA2024-12-11Camera Control Unit VP-7000X
04250480101704 - NA2024-12-11 Camera Control Unit VP-7000X
04250480101711 - NA2024-12-11 Camera Head SC-7000X
04250480101728 - NA2024-12-11 Light Guide 3.5 x 3000 mm LG-7000X
04250480101735 - NA2024-12-11 Light Guide Adapter AL-7000X
04250480112809 - NA2024-11-28 Light Guide 3.5 x 3000 mm, HT version
04250480112816 - NA2024-11-28 Light Guide 4.8 x 3000 mm
04250480112823 - NA2024-11-28 Light Guide 3.5 x 2300 mm, HT version
04250480112830 - NA2024-11-28 Light Guide 4.8 x 2300 mm

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