FDA.reportPublic FDA data

DBS-57M

Primary DI
08800018421208
Brand
DBS-57M
Company
DRTECH Corporation
Model
DBS-57M
Published
2023-09-04
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
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
08800018421208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800018421208088000184212088800018421208

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic X-ray system image receptor floor standAn electrically-powered component of a diagnostic x-ray system intended to be placed on the floor to mount, support, and facilitate positioning of an image receptor assembly (bucky) [not included]. It typically consists of a vertical rack with controls mounted on a base plate. The image receptor assembly is attached to the rack and can be moved along the rack and/or tilted.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689842626
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
08800018408209EXPD 4343SEXPD 4343S2026-03-17
08800018408308EXPD 4343DEXPD 4343D2026-03-17
08800018408407EXPD 3643DEXPD 3643D2026-03-17
08800018412008EConsole2EConsole22026-03-17
08800018424704XERO-alphaXERO α2026-03-17
08800018403808FLAATZFLAATZ 5602016-09-02
08800018422601EXTRON 3EXTRON 32025-06-17
08800018430002EXPD-N seriesEXPD 4343N12025-06-13
08800018430101EXPD-N seriesEXPD 4343N2025-06-13
08800018430200EXPD-N seriesEXPD 4343U12025-06-13
08800018430309EXPD-N seriesEXPD 4343NU2025-06-13
08800018430408EXPD-N seriesEXPD 4343NP2025-06-13
08800018430507EXPD-N seriesEXPD 3643N12025-06-13
08800018430606EXPD-N seriesEXPD 3643N2025-06-13
08800018430705EXPD-N seriesEXPD 3643U12025-06-13
08800018430804EXPD-N seriesEXPD 3643NU2025-06-13
08800018430903EXPD-N seriesEXPD 3643NP2025-06-13
08800018420805EXTRON 5EXTRON 52023-08-24
08800018420904EXTRON 7EXTRON 72023-08-24
08800018408506EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PGEXPD 1142025-03-27

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
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
08800018420706LLD 129 with rotationDRTECH CorporationIXY2022-11-29