GUDID 04250480112823

Light Guide 3.5 x 2300 mm, HT version

SCHÖLLY FIBEROPTIC GmbH

Fibreoptic light cable
Primary Device ID04250480112823
NIH Device Record Keyb0161fe3-c562-48d3-9fc4-1b7a61bfed90
Commercial Distribution StatusIn Commercial Distribution
Version Model Number05.0088l.ht
Company DUNS316276682
Company NameSCHÖLLY FIBEROPTIC GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Dimensions

Device Size Text, specify0
Length2300 Millimeter
Device Size Text, specify0
Length2300 Millimeter
Device Size Text, specify0
Length2300 Millimeter
Device Size Text, specify0
Length2300 Millimeter
Device Size Text, specify0
Length2300 Millimeter
Device Size Text, specify0
Length2300 Millimeter
Device Size Text, specify0
Length2300 Millimeter
Device Size Text, specify0
Length2300 Millimeter
Device Size Text, specify0
Length2300 Millimeter
Device Size Text, specify0
Length2300 Millimeter

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 5 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 5 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 5 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 5 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 5 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 5 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 5 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 5 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 5 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 5 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104250480112823 [Primary]

FDA Product Code

EQHSource, Carrier, Fiberoptic Light

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04250480112823]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112823]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112823]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112823]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112823]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112823]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112823]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112823]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112823]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112823]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-11-28
Device Publish Date2024-01-08

Devices Manufactured by SCHÖLLY FIBEROPTIC GmbH

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
04250480101759 - NA2025-01-23 Laparoscope 10 x 344mm, 0° RL-100
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.