Non-Telescopic PenEvac ICM-000-0595

GUDID 00817688022916

Non-Telescopic PenEvac®, Megadyne E-Z Clean Blade, 10’ Tube, Universal Connector, Non-Sterile, Bulk

I.C. MEDICAL, INC.

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID00817688022916
NIH Device Record Key13b3552d-ebd9-4d1e-8e2b-57b302669a7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNon-Telescopic PenEvac
Version Model NumberICM-000-0595
Catalog NumberICM-000-0595
Company DUNS616182895
Company NameI.C. MEDICAL, INC.
Device Count25
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 Datetrue
Expiration Datefalse
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
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
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
GS100817688022916 [Unit of Use]
GS100817688022923 [Primary]

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817688022916]

Ethylene Oxide


[00817688022916]

Ethylene Oxide


[00817688022916]

Ethylene Oxide


[00817688022916]

Ethylene Oxide


[00817688022916]

Ethylene Oxide


[00817688022916]

Ethylene Oxide


[00817688022916]

Ethylene Oxide


[00817688022916]

Ethylene Oxide


[00817688022916]

Ethylene Oxide


[00817688022916]

Ethylene Oxide


[00817688022916]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-27
Device Publish Date2020-10-19

On-Brand Devices [Non-Telescopic PenEvac]

00817688022442ICM-000-0564
00817688022213ICM-000-0558
00817688022190ICM-000-0556
00817688022077ICM-000-0550
00817688022060ICM-000-0549
00817688022022ICM-000-0544
00817688022008ICM-000-0540
00817688020783ICM-000-0538
00817688020752ICM-000-0536
00817688020745ICM-000-0534
00817688020721ICM-000-0532
00817688020707ICM-000-0530
00817688020684ICM-000-0528
00817688020660ICM-000-0526
00817688020646ICM-000-0524
00817688021803ICM-000-0522
00817688020615ICM-000-0520
00817688020592ICM-000-0518
00817688020578ICM-000-0516
00817688020554ICM-000-0514
00817688020530ICM-000-0512
00817688020516ICM-000-0510
00817688020493ICM-000-0508
00817688020417ICM-000-0496
00817688022619ICM-000-0580
00817688022596ICM-000-0578
00817688022572ICM-000-0576
00817688022831Non-Telescopic PenEvac®, Non-Stick Blade, 10’ Tube, Universal Connector, Non-Sterile, Bulk
00817688022817Non-Telescopic PenEvac®, Stainless Steel Blade, 10’ Tube, Universal Connector, Non-Sterile, B
00817688022794Non-Telescopic PenEvac®, Stainless Steel Blade, 10’ Tube, 22 mm to 10 mm Flexible Connector,
00817688022718Non-Telescopic PenEvac®, Non-Stick Blade, 10’ Tube, 22 mm to 10 mm Flexible Connector, Non-St
00817688022695Non-Telescopic PenEvac®, Non-Stick Blade, 10’ Tube, Non-Sterile, Bulk
00817688022916Non-Telescopic PenEvac®, Megadyne E-Z Clean Blade, 10’ Tube, Universal Connector, Non-Sterile
00817688022893Non-Telescopic PenEvac®, Megadyne E-Z Clean Blade, 10’ Tube, 22 mm to 10 mm Flexible Connecto
00817688023913Non-Telescopic PenEvac®, Non-Stick ENT Needle, 10 Foot Tube, Universal Connector & Holster, Ste
00817688023890Non-Telescopic PenEvac®, Stainless Steel ENT Needle, 10 Foot Tube, Universal Connector & Holste
00817688024156Non-Telescopic PenEvac®-NB , No Blade, 10 Foot Tube, Universal Connector & Holster, Sterile

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