GUDID 04250480103906

Cystoscope 2.7 mm x 110 mm, 0°

SCHÖLLY FIBEROPTIC GmbH

Rigid optical cystoscope
Primary Device ID04250480103906
NIH Device Record Key7605e086-8111-4645-b2dc-4ea3febda7ea
Commercial Distribution StatusIn Commercial Distribution
Version Model Number41-0005a
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

Device Dimensions

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104250480103906 [Primary]

FDA Product Code

FAJCystoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04250480103906]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04250480103906]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04250480103906]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04250480103906]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04250480103906]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04250480103906]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04250480103906]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04250480103906]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04250480103906]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04250480103906]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04250480103906]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04250480103906]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04250480103906]

High-level Disinfectant;Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-17
Device Publish Date2025-04-09

Devices Manufactured by SCHÖLLY FIBEROPTIC GmbH

04250480103906 - NA2025-04-17Cystoscope 2.7 mm x 110 mm, 0°
04250480103906 - NA2025-04-17 Cystoscope 2.7 mm x 110 mm, 0°
04250480100271 - NA2025-01-23 Adapter light guide, Storz light source
04250480100288 - NA2025-01-23 Adapter light guide, Olympus light source
04250480100295 - NA2025-01-23 Adapter light guide, Wolf light source
04250480100325 - NA2025-01-23 Adapter light guides, ACMI light source
04250480100349 - NA2025-01-23 Adapter light guide, Storz endoscope
04250480100356 - NA2025-01-23 Adapter light guide, Wolf Endoscope
04250480100363 - NA2025-01-23 Adapter light guide, ACMI endoscope
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