GUDID 04250480109076

NIR FI Camera Head Full HD Zoom

SCHÖLLY FIBEROPTIC GmbH

Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera
Primary Device ID04250480109076
NIH Device Record Keydfeddbf8-d897-49b5-a739-2406f62c3258
Commercial Distribution StatusIn Commercial Distribution
Version Model Number95-3908
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
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 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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104250480109076 [Primary]

FDA Product Code

FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

[04250480109076]

Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-07
Device Publish Date2023-10-30

Devices Manufactured by SCHÖLLY FIBEROPTIC GmbH

04250480102329 - NA2023-11-07 Laparoscope 5 x 312 mm, 0°
04250480102336 - NA2023-11-07 Laparoscope 5 x 312 mm, 30°
04250480109038 - NA2023-11-07 NIR FI Light Guide, 4.8 x 3000 mm
04250480109052 - NA2023-11-07 Laparoscope 10 x 344 mm, 0°, NIR
04250480109069 - NA2023-11-07 Laparoscope 10 x 344 mm, 30°, NIR
04250480109076 - NA2023-11-07NIR FI Camera Head Full HD Zoom
04250480109076 - NA2023-11-07 NIR FI Camera Head Full HD Zoom
04250480109083 - NA2023-11-07 NIR FI CCU Full HD
04250480109045 - N/A2023-11-01 NIR FI Light Source
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