Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal® ICM-000-0718

GUDID 00817688024330

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

I.C. MEDICAL, INC.

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

Primary Device ID	00817688024330
NIH Device Record Key	74b2cc34-d67f-47ba-b288-259e8c5cb291
Commercial Distribution Status	In Commercial Distribution
Brand Name	Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®
Version Model Number	ICM-000-0718
Catalog Number	ICM-000-0718
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	00817688024323 [Primary]
GS1	00817688024330 [Package] Contains: 00817688024323 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