Light Jacket

GUDID 00860000230704

The Light Jacket® Attachable Light for Electrosurgical Pencil is offered as a sterile, one-time use disposable medical device for providing enhanced illumination of the surgical site when attached to an electrosurgical pencil.

PATHY MEDICAL, LLC

Operating room light

• Primary Device ID: 00860000230704
• NIH Device Record Key: 8e1ddfbb-d6f5-4a66-a817-5bb32408c905
• Commercial Distribution Discontinuation: 2030-06-17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Light Jacket
• Version Model Number: PM-LJ100
• Company DUNS: 081509024
• Company Name: PATHY MEDICAL, LLC
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2038168000
• Email: customerservice@pathymedical.com
• Phone: 2038168000
• Email: customerservice@pathymedical.com
• Phone: 2038168000
• Email: customerservice@pathymedical.com
• Phone: 2038168000
• Email: customerservice@pathymedical.com
• Phone: 2038168000
• Email: customerservice@pathymedical.com
• Phone: 2038168000
• Email: customerservice@pathymedical.com
• Phone: 2038168000
• Email: customerservice@pathymedical.com
• Phone: 2038168000
• Email: customerservice@pathymedical.com
• Phone: 2038168000
• Email: customerservice@pathymedical.com
• Phone: 2038168000
• Email: customerservice@pathymedical.com
• Phone: 2038168000
• Email: customerservice@pathymedical.com
• Phone: 2038168000
• Email: customerservice@pathymedical.com
• Phone: 2038168000
• Email: customerservice@pathymedical.com
• Phone: 2038168000
• Email: customerservice@pathymedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000230704 [Unit of Use]
GS1	00860000230711 [Primary]

FDA Product Code

• FTD: Lamp, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-01-08
• Device Publish Date: 2020-06-17