GUDID 04250480112809

Light Guide 3.5 x 3000 mm, HT version

SCHÖLLY FIBEROPTIC GmbH

Fibreoptic light cable
Primary Device ID04250480112809
NIH Device Record Key1547e36b-fbf8-40e9-bdaf-4dfaacff0d1c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number05.0085l.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

Length3000 Millimeter
Device Size Text, specify0
Length3000 Millimeter
Device Size Text, specify0
Length3000 Millimeter
Device Size Text, specify0
Length3000 Millimeter
Device Size Text, specify0
Length3000 Millimeter
Device Size Text, specify0
Length3000 Millimeter
Device Size Text, specify0
Length3000 Millimeter
Device Size Text, specify0
Length3000 Millimeter
Device Size Text, specify0
Length3000 Millimeter
Device Size Text, specify0
Length3000 Millimeter
Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104250480112809 [Primary]

FDA Product Code

EQHSource, Carrier, Fiberoptic Light

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04250480112809]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112809]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112809]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112809]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112809]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112809]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112809]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112809]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112809]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04250480112809]

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

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04250480101759 - NA2025-01-23 Laparoscope 10 x 344mm, 0° RL-100
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