PenEvac1

GUDID 00817688020370

I.C. MEDICAL, INC.

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID00817688020370
NIH Device Record Key27d592d5-47c7-4e82-917e-fb6607cccecd
Commercial Distribution StatusIn Commercial Distribution
Brand NamePenEvac1
Version Model NumberICM-000-0492
Company DUNS616182895
Company NameI.C. MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com
Phone623-780-0700
Emailinquiry@icmedical.com

Operating and Storage Conditions

Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817688020363 [Primary]
GS100817688020370 [Package]
Contains: 00817688020363
Package: [25 Units]
In Commercial Distribution
GS100817688022664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

[00817688020370]

Ethylene Oxide

[00817688020370]

Ethylene Oxide

[00817688020370]

Ethylene Oxide

[00817688020370]

Ethylene Oxide

[00817688020370]

Ethylene Oxide

[00817688020370]

Ethylene Oxide

[00817688020370]

Ethylene Oxide

[00817688020370]

Ethylene Oxide

[00817688020370]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-08
Device Publish Date2016-09-24

On-Brand Devices [PenEvac1]

00817688022459ICM-000-0562
00817688022176ICM-000-0554
00817688022152ICM-000-0552
00817688022053ICM-000-0548
00817688022046ICM-000-0547
00817688022039ICM-000-0545
00817688022015ICM-000-0541
00817688021926ICM-000-0502
00817688021919ICM-000-0497
00817688020479ICM-000-0506
00817688020455ICM-000-0500
00817688020431ICM-000-0498
00817688020394ICM-000-0494
00817688020370ICM-000-0492
00817688020271ICM-000-0478
00817688020257ICM-000-0476
00817688020233ICM-000-0474
00817688020219ICM-000-0472
00817688020196ICM-000-0470
00817688020172ICM-000-0468
00817688020158ICM-000-0466
00817688020134ICM-000-0464
00817688020110ICM-000-0462
00817688020097ICM-000-0458
00817688020073ICM-000-0456
00817688020059ICM-000-0454
00817688020028ICM-000-0450
00817688020004ICM-000-0452
00817688022558ICM-000-0574
00817688022534ICM-000-0572
00817688022510ICM-000-0570
00817688022633ICM-000-0596
00817688022770PenEvac1®, Non-Stick Blade, 10’ Tube, Universal Connector, Non-Sterile, Bulk
00817688022756PenEvac1®, Stainless Steel Blade, 10’ Tube, Universal Connector, Non-Sterile, Bulk
00817688022732PenEvac1®, Stainless Steel Blade, 10’ Tube, 22 mm to 10 mm Flexible Connector, Non-Sterile, B
00817688022671PenEvac1®, Non-Stick Blade, 10’ Tube, 22 mm to 10 mm Flexible Connector, Non-Sterile, Bulk
00817688022879PenEvac1®, Megadyne E-Z Clean Blade, 10’ Tube, Universal Connector, Non-Sterile, Bulk
00817688022855PenEvac1®, Megadyne E-Z Clean Blade, 10’ Tube, 22mm to 10mm Flexible Connector, Non-Sterile,
00817688023876PenEvac1®, Non-Stick ENT Needle, 10 Foot Tube, Universal Connector & Holster, Sterile
00817688023852PenEvac1®, Stainless Steel ENT Needle, 10 Foot Tube, Universal Connector & Holster, Sterile
00817688023937PenEvac1, Non-Stick Blade, 14-Foot Tube, 15-Foot Cable, Universal Connector & Holster, Sterile
00817688024132PenEvac1®-NB, No Blade, 10 Foot Tube, Universal Connector & Holster, Sterile

Trademark Results [PenEvac1]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PENEVAC1
PENEVAC1
85528850 4339601 Live/Registered
I.C. Medical, Inc.
2012-01-30
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