GUDID 04250480109038

NIR FI Light Guide, 4.8 x 3000 mm

SCHÖLLY FIBEROPTIC GmbH

Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable
Primary Device ID04250480109038
NIH Device Record Keybb36b009-18bc-4636-b50f-b445fe58095b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number05-0094l-nir
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
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
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
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

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
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
GS104250480109038 [Primary]

FDA Product Code

EQHSource, Carrier, Fiberoptic Light

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


[04250480109038]

Moist Heat or Steam Sterilization


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 - NA2023-11-07NIR FI Light Guide, 4.8 x 3000 mm
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 - NA2023-11-07 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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