AccessGUDID - DEVICE: SENTINELLA (08437018413027)

GUDID

Device Identifier (DI) Information

Brand Name: SENTINELLA
Version or Model: SENTINELLA 102 HORUS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FP-0055
Company Name: GENERAL EQUIPMENT FOR MEDICAL IMAGING SA

Primary DI Number: 08437018413027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 463337670 *Terms of Use

Device Description: Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients. Sentinella presents the following modalities: • Sentinella 102 (this record) • Sentinella 102 Horus

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?
40641	Mobile gamma camera system	An assembly of mobile diagnostic devices designed to record, quantify, and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. It uses Anger or non-Anger detection methods and consists of an analogue or digital detector based nuclear medicine (NM) planar imaging system, a sodium iodide (Nal) crystal(s), a collimator and a set of photomultiplier tubes. Gamma rays pass through holes in the collimator causing light flashes within the crystal corresponding to the sites of origin in the body and the amplitude of the flash is calculated by a computer to create images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYX	Camera, Scintillation (Gamma)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162052	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 185 Centimeter
Depth: 77 Centimeter
Width: 63 Centimeter
Weight: 134 Kilogram

Device Record Status

Public Device Record Key: c32cc50c-e097-481f-aba9-5a7cb77965a9
Public Version Date: January 24, 2022
Public Version Number: 1
DI Record Publish Date: January 14, 2022