FDA.reportPublic FDA data

DRGEM

Primary DI
08800011101022
Brand
DRGEM
Company
DRGEM Corporation
Model
PBT-6
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
IZZTable, Radiographic, Non-Tilting, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZZTable, Radiographic, Non-Tilting, PoweredRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800011101022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800011101022088000111010228800011101022

GMDN Terms#

Term, Definition table
TermDefinition
Basic diagnostic x-ray system table, poweredA powered/programmable table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery.

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
08800011101145DRGEMDRGEM CorporationIZZ2025-02-11
05999116100023PHOENIX 1CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIZZ2024-10-30
S062110000ElevatorMaxPausch, L.L.C.IZZ2024-04-24
05999116100054PHOENIX 2CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIZZ2023-08-15
B884S06211100L0CombiMaxPausch, L.L.C.IZZ2022-12-28
B884S06211100R0CombiMaxPausch, L.L.C.IZZ2022-12-28
00195278527455NAGE Hualun Medical Systems Co., LtdIZZ2022-07-21
00858340006134Del Medical, Inc.Del Medical, Inc.IZZ2022-04-15
00195278012258NAGE Hualun Medical Systems Co., LtdIZZ2020-11-24
00840682140942NAGE Hangwei Medical Systems Company Ltd.IZZ2018-11-09
00840682141895NAGE Hangwei Medical Systems Company Ltd.IZZ2018-11-09
00840682141932NAGE Hualun Medical Systems Co., LtdIZZ2018-11-06
60889978606801DRX - Ascend SystemCARESTREAM HEALTH, INC.IZZ2018-01-15
00850977007058IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007065IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007072IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007089IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007096IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007188IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007195IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007201IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007218IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007225IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00840682102674NAGE Hangwei Medical Systems Company Ltd.IZZ2017-07-28
00840682103572NAGE Healthcare Japan CorporationIZZ2017-07-17
08800011101008DRGEMDRGEM CorporationIZZ2017-05-29
08800011101015DRGEMDRGEM CorporationIZZ2017-05-29
08800011100018DRGEMDRGEM CorporationIZZ2017-05-29
00850977007171IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-05-18
00850977007041IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-02-02