AccessGUDID - DEVICE: GammaPro Hi-Sense Probe with Tablet and Carry Case (B619GPROHISKIT0)

GUDID

Device Identifier (DI) Information

Brand Name: GammaPro Hi-Sense Probe with Tablet and Carry Case
Version or Model: K0019C02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Kubtec

Primary DI Number: B619GPROHISKIT0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 361955128 *Terms of Use

Device Description: GammaPro Hi-Sense Probe with Tablet and Carry Case used for wireless ionizing radiation detection.

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:	Yes
Combination Product:	No
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
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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b04293a2-331c-4ae3-8779-a6f60d5813d1
Public Version Date: October 24, 2022
Public Version Number: 1
DI Record Publish Date: October 14, 2022