Home GUDID 00198953054949 NA
Primary DI 00198953054949
Brand NA
Company GE Hualun Medical Systems Co., Ltd
Model GCTS-C11
Device description Gemini Tubestand MSX made
Published 2025-09-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name IYB Tube Mount, X-Ray, Diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IYB Tube Mount, X-Ray, Diagnostic Radiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00198953054949 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 00198953054949 00198953054949 198953054949 0198953054949
GMDN Terms# Term, Definition table Term Definition Stationary basic diagnostic x-ray system, digital An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.
Regulatory Flags# DUNS number 554408665 Device count 1 Premarket exempt true Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00195278901880 NA GE Hualun Medical Systems Co., Ltd IYB 2025-06-09 00860008892768 Foot and Ankle Stand OXOS Medical, Inc. IYB 2025-06-02 08800011103088 DRGEM DRGEM Corporation IYB 2024-10-24 08800011103095 DRGEM DRGEM Corporation IYB 2024-10-24 08800011103125 DRGEM DRGEM Corporation IYB 2024-10-24 08800011103132 DRGEM DRGEM Corporation IYB 2024-10-24 08800011103163 DRGEM DRGEM Corporation IYB 2024-10-24 08800011103170 DRGEM DRGEM Corporation IYB 2024-10-24 08809832900258 SD-3100 SHINYOUNG FOR M CO.,LTD. IYB 2024-04-04 B884SVMS4000 VMS 400 Pausch, L.L.C. IYB 2024-02-16 08809832900074 LSS-2000 SHINYOUNG FOR M CO.,LTD. IYB 2023-11-20 08809832900098 SST-3100 SHINYOUNG FOR M CO.,LTD. IYB 2023-11-20 08809832900104 SST-3001 SHINYOUNG FOR M CO.,LTD. IYB 2023-11-20 08809832900227 SS-2100 SHINYOUNG FOR M CO.,LTD. IYB 2023-11-20 08809832900234 SS-2100 SHINYOUNG FOR M CO.,LTD. IYB 2023-11-20 05999116100269 F100 TS99N TUBE MOUNT CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő Részvénytársaság IYB 2023-08-15 D678A63410 "Provecta HD 16"" Center to Center Wall Mounting Plate" AIR TECHNIQUES, INC. IYB 2023-07-11 D678A63890 Provecta HD Single Post Mounting Plate AIR TECHNIQUES, INC. IYB 2023-07-11 D678A63301 Provecta HD 16" Center to Center Wall Mounting Plate AIR TECHNIQUES, INC. IYB 2023-07-11 D678A63361 Provecta HD Single Post Mounting Plate AIR TECHNIQUES, INC. IYB 2023-07-11 B884S10000110R0 Paxis 100 Auto Pausch, L.L.C. IYB 2023-05-12 S10000110R0 Paxis 100 Auto Pausch, L.L.C. IYB 2023-05-03 B884S10000110L0 Paxis 100 Auto Pausch, L.L.C. IYB 2023-05-03 B884S04201000L0 Cirrus Pausch, L.L.C. IYB 2022-12-23 B884S04201000R0 Cirrus Pausch, L.L.C. IYB 2022-12-23 B884S100002000 Paxis 200 Pausch, L.L.C. IYB 2022-12-23 B884S10000100L0 Paxis 100 Pausch, L.L.C. IYB 2022-12-06 B884S10000100R0 Paxis 100 Pausch, L.L.C. IYB 2022-12-06 00195278569745 NA GE Hualun Medical Systems Co., Ltd IYB 2022-07-21 00195278569813 NA GE Hualun Medical Systems Co., Ltd IYB 2022-07-21