InMode RF hand piece HP172206A

GUDID 17290016633228

HPL17D22 06A

INMODE M.D LTD

Radio-frequency ablation system generator Radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator

• Primary Device ID: 17290016633228
• NIH Device Record Key: 08cc7b98-3be2-4e90-8f37-6d6d3f630a17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InMode RF hand piece
• Version Model Number: HP172206A
• Catalog Number: HP172206A
• Company DUNS: 600417351
• Company Name: INMODE M.D LTD
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016633221 [Unit of Use]
GS1	17290016633228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163190

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[17290016633228]

Dry Heat Sterilization

[17290016633228]

Dry Heat Sterilization

[17290016633228]

Dry Heat Sterilization

[17290016633228]

Dry Heat Sterilization

[17290016633228]

Dry Heat Sterilization

[17290016633228]

Dry Heat Sterilization

[17290016633228]

Dry Heat Sterilization

[17290016633228]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-14

On-Brand Devices [InMode RF hand piece]

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• 07290016633481: AccuTite
• 07290016633467: InMode RF Applicator
• 07290016633450: InMode RF Applicator
• 07290019863052: Handpiece comprises internal active electrode, external return electrode, both with temperature
• 07290019863045: Handpiece comprises internal active electrode, external return electrode, both with temperature