Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal® ICM-000-0716

GUDID 00817688024316

Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick ENT Needle, 10 Foot Tube, 22mm to 10mm to Connector and Holster, Sterile

I.C. MEDICAL, INC.

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 00817688024316
• NIH Device Record Key: 452cc2af-93b8-4733-b523-8eabcf0e3b3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®
• Version Model Number: ICM-000-0716
• Catalog Number: ICM-000-0716
• Company DUNS: 616182895
• Company Name: I.C. MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com
• Phone: 6237800700
• Email: inquiry@icmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817688024309 [Primary]
GS1	00817688024316 [Package]; Contains: 00817688024309; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-25
• Device Publish Date: 2023-10-17

On-Brand Devices [Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®]

• 00817688024118: Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®, 100 mm Guarded Non-Stick Blade, 10 Foo
• 00817688024071: Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®, 100 mm Guarded Non-Stick Blade, 10 Foo
• 00817688024033: Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®, 70 mm Guarded Non-Stick Blade, 10 Foot
• 00817688023999: Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®, 70 mm Guarded Non-Stick Blade, 10 Foot
• 00817688024279: Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick Blade, 10
• 00817688024255: Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick Blade, 10
• 00817688024231: Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick Blade, 10
• 00817688024330: Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick ENT Needle
• 00817688024316: Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick ENT Needle
• 00817688024293: Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick ENT Needle