FDA.reportPublic FDA data

DRGEM

Primary DI
08800011102005
Brand
DRGEM
Company
DRGEM Corporation
Model
WBS
Published
2017-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IXYHolder, Radiographic Cassette, Wall-Mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXYHolder, Radiographic Cassette, Wall-MountedRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800011102005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800011102005088000111020058800011102005

GMDN Terms#

Term, Definition table
TermDefinition
X-ray film cassette holderA device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).

Regulatory Flags#

DUNS number
688477319
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800011150129DRGEMRAYMO2026-05-20
08800011150136DRGEMRAYMO2026-05-20
08800011140076DRGEMGXR-52SD2019-10-07
08800011140090DRGEMGXR-82SD2019-10-07
08800011140106DRGEMGXR-C32SD2019-10-07
08800011140113DRGEMGXR-C40SD2019-10-07
08800011140120DRGEMGXR-C52SD2019-10-07
08800011140137DRGEMGXR-U32SD2019-10-07
08800011140144DRGEMGXR-U40SD2019-10-07
08800011140182DRGEMGXR-32SD2019-10-07
08800011140199DRGEMGXR-32SD2019-10-07
08800011140205DRGEMGXR-32SD2019-10-07
08800011140212DRGEMGXR-32SD2019-10-07
08800011140229DRGEMGXR-40SD2019-10-07
08800011140236DRGEMGXR-40SD2019-10-07
08800011140243DRGEMGXR-40SD2019-10-07
08800011140250DRGEMGXR-40SD2019-10-07
08800011140267DRGEMGXR-52SD2019-10-07
08800011140274DRGEMGXR-68SD2019-10-07
08800011140281DRGEMGXR-82SD2019-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858340006547Del Medical, Inc.Del Medical, Inc.IXY2026-03-05
00198953043288NAGE Hualun Medical Systems Co., LtdIXY2025-04-22
00198953043295NAGE Hualun Medical Systems Co., LtdIXY2025-04-22
00198953023259NAGE Hualun Medical Systems Co., LtdIXY2025-02-28
00198953023266NAGE Hualun Medical Systems Co., LtdIXY2025-02-28
08800018422502LLD 86 BasicDRTECH CorporationIXY2024-05-08
05999116186119Z-MOTION STANDCONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIXY2023-12-04
08809832900111SU-2100SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900128SU-4500SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900159LSS-1000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900166SU-2000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900173SD-3500SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900180SU-4000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900197SD-6000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900241SD-6000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08800018421307LLD 129 BasicDRTECH CorporationIXY2023-11-03
08800018421406LLD 129 without rotationDRTECH CorporationIXY2023-11-03
08800018421208DBS-57MDRTECH CorporationIXY2023-09-04
05999116100580WS99(N) WALL STANDCONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIXY2023-08-15
05055449402958KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2023-07-11
05055449415927KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2023-07-11
00858340006387Del Medical, Inc.Del Medical, Inc.IXY2023-05-16
08800018421000LLD 129 CompactDRTECH CorporationIXY2023-04-12
08800018421109LLD 129 SamsungDRTECH CorporationIXY2023-04-12
07350011170111! Mobile wallstandSolutions For Tomorrow ABIXY2023-03-09
B884SFS100L0FS 100 WallstandPausch, L.L.C.IXY2022-12-28
B884SFS100R0FS 100 WallstandPausch, L.L.C.IXY2022-12-28
05055449415705KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2022-12-08
05055449415910KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2022-12-08
05055449415934KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2022-12-08