FDA.reportPublic FDA data

I-Tek I-150 LED Light Source

Primary DI
00869836000307
Brand
I-Tek I-150 LED Light Source
Company
I-Tek Medical, Inc.
Model
I-150
Catalog number
I-150
Device description
The LED Light Source is the light source for use with the Medical Illumination Light Enhancement System. It is a compact size with a small footprint, light, easily portable, has infinitely variable light output and is maintenance free with a long lifetime expectancy.
Published
2017-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCWLight Source, Fiberoptic, Routine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCWLight Source, Fiberoptic, RoutineGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869836000307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869836000307008698360003078698360003070869836000307

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose light sourceA mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth7.25Inch
Height3.32Inch
Weight1.14Kilogram
Width4.65Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure524.4 Millimeter of Mercury794.96 Millimeter of Mercury
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure524.4 Millimeter of Mercury794.96 Millimeter of Mercury
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-454-6602sales@i-tekmedical.com

Regulatory Flags#

DUNS number
080599644
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869836000314Fiber Optic Illuminator1136-0012018-12-06
00869836000321Fiber Optic Illuminator1102-0012019-05-28
00869836000345Fiber Optic Illuminator1090-0012019-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047788607GimmiGimmi GmbHFCW2026-03-04
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFCW2025-06-11
00855373008029StrykerSUNOPTIC TECHNOLOGIES LLCFCW2025-05-15
04049047788522GimmiGimmi GmbHFCW2025-03-20
04048551366813n.a.Karl Storz GmbH & Co. KGFCW2024-11-28
00840183528577BR Surgical, LLCBR Surgical, LLCFCW2024-10-24
04049197465007RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFCW2024-09-20
04049197465069RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFCW2024-09-20
00840183507763BR Surgical, LLCBR Surgical, LLCFCW2024-07-22
00840183527341BR Surgical, LLCBR Surgical, LLCFCW2024-07-22
04250480109045N/ASCHÖLLY FIBEROPTIC GmbHFCW2023-10-24
04961333071333PENTAXHOYA CORPORATIONFCW2023-07-31
04961333238088PENTAXHOYA CORPORATIONFCW2023-07-31
M678SLSS0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerSUNOPTIC TECHNOLOGIES LLCFCW2023-03-01
00840319710616Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710623Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710630Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710647Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710654Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710661Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710678Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710685Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710692Hayden MedicalHayden Medical, Inc.FCW2022-07-28
G043MLGA4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGA4X7ST0BEARBear-Ent, LLCFCW2022-05-19
G043MLGO4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGO4X7ST0BEARBear-Ent, LLCFCW2022-05-19
G043MLGS4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGS4X7ST0BEARBear-Ent, LLCFCW2022-05-19
07613327051568NASTRYKER CORPORATIONFCW2021-07-07