WPROBE

DI: 08437018413072 · Model: STD · GENERAL EQUIPMENT FOR MEDICAL IMAGING SA

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Product Codes

GMDN Terms

Identifiers

Pkg Device Count

Basic Information

Brand Name: WPROBE
Primary DI: 08437018413072
Version / Model: STD
Catalog Number: IC-1150
Company Name: GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
Labeler DUNS: 463337670
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2021-12-01
Public Version: 2
Public Version Date: 2023-01-19
Public Version Status: Update
Public Device Record Key: 8601b33f-fe07-4244-b113-24f48ab6bd1b

Device Description

GAMMAPRO 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. GAMMAPRO is comprised of the probe and the software installed in a control unit that is compatible with its use. GAMMAPRO is presented in 4 models: normal (GAMMAPRO STD), High Sensitivity (GAMMAPRO Hi-S), laparoscopic (GAMMAPRO LAP model) and ANGLED (GAMMAPRO ANG).

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: Yes
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: Yes
PM Exempt: Yes
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: Yes
Sterilization Methods: Hydrogen Peroxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZD	Probe, Uptake, Nuclear	Radiology	892.1320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65055	Intraoperative gamma radiation detection system probe, reusable	An electrically-powered, invasive component of an intraoperative gamma radiation detection system intended to be introduced into the body during a surgical procedure to detect and quantify gamma radiation emitted from previously-administered radiopharmaceuticals (e.g., localized in sentinel lymph nodes), in conjunction with a dedicated control unit (not included). It is typically manipulated using surgical forceps and incorporates a crystal scintillator and photomultiplier. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08437018413072	GS1

Device Sizes

Type	Value	Unit
Length	255	Millimeter
Weight	162	Gram
Width	40	Millimeter
Height	40	Millimeter

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -20 – 60 Degrees Celsius
Type: Handling Environment Temperature
Temperature Range: 10 – 40 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 30 – 70 Percent (%) Relative Humidity
Type: Storage Environment Humidity
Temperature Range: 30 – 70 Percent (%) Relative Humidity