GUDID 04250480100257

Light Guide 4.8 x 2300 mm

SCHÖLLY FIBEROPTIC GmbH

Fibreoptic light cable
Primary Device ID04250480100257
NIH Device Record Keycdf10a90-4d97-4042-a7ec-93864603b818
Commercial Distribution StatusIn Commercial Distribution
Version Model Number05.0090l
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
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
Device Size Text, specify0
Length2300 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104250480100257 [Primary]

FDA Product Code

EQHSource, Carrier, Fiberoptic Light

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04250480100257]

Moist Heat or Steam Sterilization

[04250480100257]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04250480100257]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04250480100257]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04250480100257]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04250480100257]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04250480100257]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04250480100257]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04250480100257]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04250480100257]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[04250480100257]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-13

Devices Manufactured by SCHÖLLY FIBEROPTIC GmbH

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.