AccessGUDID - DEVICE: GAMMAPRO (08437018413294)

GUDID

Device Identifier (DI) Information

Brand Name: GAMMAPRO
Version or Model: ANGLED
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IC-1180
Company Name: GENERAL EQUIPMENT FOR MEDICAL IMAGING SA

Primary DI Number: 08437018413294
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 463337670 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZD	Probe, Uptake, Nuclear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Hydrogen Peroxide

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Length: 259 Millimeter
Weight: 122 Gram
Width: 40 Millimeter
Height: 40 Millimeter

Device Record Status

Public Device Record Key: dd9bb6c7-4540-4869-9cf8-306d443022ba
Public Version Date: January 26, 2023
Public Version Number: 1
DI Record Publish Date: January 18, 2023