Home GUDID 03770020839009 BoneView
Primary DI 03770020839009
Brand BoneView
Company GLEAMER
Model 1.X-US
Published 2022-04-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03770020839009 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03770020839009 03770020839009 3770020839009
GMDN Terms# Term, Definition table Term Definition Radiological PACS-dedicated management software A software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.
Regulatory Flags# DUNS number 281142375 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes#