Home GUDID 00198953183984 Lunar
Primary DI 00198953183984
Brand Lunar
Company GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC
Model Astra
Device description Lunar Astra, Full, WH Ready
Published 2026-10-19
Public version status New
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 KGI Densitometer, Bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KGI Densitometer, Bone Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00198953183984 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00198953183984 00198953183984 198953183984 0198953183984
GMDN Terms# Term, Definition table Term Definition Bone absorptiometric x-ray system, dual-energy An assembly of devices designed for bone density measurements and other calculations based on data obtained using a two distinct photon energy peak. Also referred to as a bone densitometer. It utilizes an x-ray tube or tubes as the photon source which are mechanically aligned and moves along with a photon detector assembly typically in a rectilinear pattern. The collimated beam is directed through an anatomical region of interest and the differential absorption patterns are detected. This information is used in calculations to estimate bone mineral density (osteoporosis), subcutaneous fat, fracture risk.
Regulatory Flags# DUNS number 144874033 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860016420908 AutoBMD Heart Lung Corporation KGI 2026-09-04 00860016420922 AI-CVD Heart Lung Corporation KGI 2026-09-04 08437021740066 3D-SHAPER 3D-SHAPER MEDICAL S.L. KGI 2026-05-12 B214OSTBSIV400 TBS iNsight medimaps group SA KGI 2025-02-13 08437021740028 3D-SHAPER 3D-SHAPER MEDICAL S.L. KGI 2023-10-04 B052PHCTM40 Model 4 CT Calibration Phantom MINDWAYS SOFTWARE, INC. KGI 2023-05-04 B214OSPTMV30 Phantom medimaps group SA KGI 2022-12-08 B214OSPTM3 Phantom medimaps group SA KGI 2022-12-08 B214OSTBSI3120 TBS iNsight medimaps group SA KGI 2022-01-13 00866955000478 IlluminatusDXA Software Norland at Swissray KGI 2020-07-27 B214OSTBSI3110 TBS iNsight medimaps group SA KGI 2020-06-25 B214OSTBSI3100 TBS iNsight medimaps group SA KGI 2020-02-28 B214OSTBSI303 TBS iNsight medimaps group SA KGI 2018-08-30 00860000233101 VirtuOst O N DIAGNOSTICS LLC KGI 2018-08-15 00840682138345 Prodigy GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC KGI 2018-07-03 00840682138352 Prodigy GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC KGI 2018-07-03 15420045507494 APEX Practice Managment Tool Hologic, Inc. KGI 2018-04-04 00866955000409 XR-600 Basic Norland at Swissray KGI 2017-11-16 00866955000416 XR-600 Clinical Norland at Swissray KGI 2017-11-16 00866955000423 XR-600 Advanced Norland at Swissray KGI 2017-11-16 00866955000430 XR-800 Basic Norland at Swissray KGI 2017-11-16 00866955000447 XR- 800 Clinical Norland at Swissray KGI 2017-11-16 00866955000454 XR-800 Advanced Norland at Swissray KGI 2017-11-16 00866955000461 Elite Norland at Swissray KGI 2017-11-16 15420045506893 Discovery SL Hologic, Inc. KGI 2017-11-15 15420045506909 Discovey C Hologic, Inc. KGI 2017-11-15 15420045506916 Discovery W Hologic, Inc. KGI 2017-11-15 15420045506879 Discovery A Hologic, Inc. KGI 2017-09-22 04260491560018 NA Stratec Medizintechnik GmbH KGI 2017-04-26 04260491560025 NA Stratec Medizintechnik GmbH KGI 2017-04-26