WPROBE IC-1150

GUDID 08437018413072

Wprobe is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity. Wprobe is comprised of the probe and the software installed in a control unit that is compatible with its use. Wprobe is presented in 3 models: normal (Wprobe STD), High Sensitivity (Wprobe Hi-S) and laparoscopic (Wprobe LAP model).

GENERAL EQUIPMENT FOR MEDICAL IMAGING SA

Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable Intraoperative gamma radiation detection system probe, reusable
Primary Device ID08437018413072
NIH Device Record Key8601b33f-fe07-4244-b113-24f48ab6bd1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameWPROBE
Version Model NumberSTD
Catalog NumberIC-1150
Company DUNS463337670
Company NameGENERAL EQUIPMENT FOR MEDICAL IMAGING SA
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter
Length255 Millimeter
Weight162 Gram
Width40 Millimeter
Height40 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108437018413072 [Primary]

FDA Product Code

IZDProbe, Uptake, Nuclear

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


[08437018413072]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-09
Device Publish Date2021-12-01

On-Brand Devices [WPROBE]

08437018413096Wprobe is a wireless ionizing radiation detector probe for use in the medical environment. The i
08437018413089Wprobe is a wireless ionizing radiation detector probe for use in the medical environment. The i
08437018413072Wprobe is a wireless ionizing radiation detector probe for use in the medical environment. The

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