ESU Shroud ICM-000-0598

GUDID 00817688022657

ESU Shroud, Short Tip, 1’ Tube, Sterile

I.C. MEDICAL, INC.

Surgical plume evacuation system tube
Primary Device ID00817688022657
NIH Device Record Key5d251daf-5732-46c2-8b71-5be7d3f53914
Commercial Distribution StatusIn Commercial Distribution
Brand NameESU Shroud
Version Model NumberICM-000-0598
Catalog NumberICM-000-0598
Company DUNS616182895
Company NameI.C. MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
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
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 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
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817688022640 [Primary]
GS100817688022657 [Package]
Contains: 00817688022640
Package: [25 Units]
In Commercial Distribution

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-16
Device Publish Date2023-03-08

On-Brand Devices [ESU Shroud]

00817688022404ICM-000-0560
00817688021995ICM-000-0543
00817688021988ICM-000-0542
00817688021971ICM-000-0449
00817688021940ICM-000-0175
00817688021933ICM-000-0101
00817688021209ICM-000-0357
00817688021186ICM-000-0301E
00817688021162ICM-000-0226
00817688021124ICM-000-0169
00817688021100ICM-000-0166
00817688021087ICM-000-0148
00817688021063ICM-000-0017
00817688022497ICM-000-0568
00817688022657ESU Shroud, Short Tip, 1’ Tube, Sterile

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