I-Tek I-150 LED Light Source I-150

GUDID 00869836000307

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.

I-TEK MEDICAL SOLUTIONS, INC.

General-purpose light source

• Primary Device ID: 00869836000307
• NIH Device Record Key: 3a9a4dae-e9a3-437b-bf63-57b1e59a56df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-Tek I-150 LED Light Source
• Version Model Number: I-150
• Catalog Number: I-150
• Company DUNS: 080599644
• Company Name: I-TEK MEDICAL SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 651-454-6602
• Email: sales@i-tekmedical.com

Device Dimensions

• Weight: 1.14 Kilogram
• Weight: 1.14 Kilogram
• Weight: 1.14 Kilogram
• Weight: 1.14 Kilogram

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869836000307 [Primary]

FDA Product Code

• FCW: Light Source, Fiberoptic, Routine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-06-23

Devices Manufactured by I-TEK MEDICAL SOLUTIONS, INC.

• 10869836000328 - Fiber Optic Illuminator: 2019-06-05
• 00869836000345 - Fiber Optic Illuminator: 2019-06-05
• 10869836000311 - Fiber Optic Illuminator: 2019-01-07
• 00869836000307 - I-Tek I-150 LED Light Source: 2018-03-29The 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.
• 00869836000307 - I-Tek I-150 LED Light Source: 2018-03-29 The LED Light Source is the light source for use with the Medical Illumination Light Enhancement System. It is a compact size wi