FDA.reportPublic FDA data

SEDECAL

Primary DI
08436046000995
Brand
SEDECAL
Company
SEDECAL
Model
MILL-FMTSAD
Device description
Floor mounted diagnostic x-ray tube stand
Published
2016-10-28
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
IYBTube Mount, X-Ray, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYBTube Mount, X-Ray, DiagnosticRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436046000995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436046000995084360460009958436046000995

GMDN Terms#

Term, Definition table
TermDefinition
X-ray system tube support, floor standingA component of an x-ray system (diagnostic, therapeutic, radiation therapy simulator) intended to be placed on the floor to mount, support and facilitate positioning of the x-ray tube assembly (not included). It typically consists of a rack with controls mounted on a base plate. The x-ray tube assembly is attached to the rack and can be moved along the rack and/or tilted. Some designs also support the movement and positioning of an image receptor assembly (e.g., C-arm assembly).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
510948979
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
08436046003651SEDECALODYSSEY24202025-03-21
08436046003668SEDECALODYSSEY24322025-03-21
08436046003675SEDECALODYSSEY24402025-03-21
08436046003682SEDECALODYSSEY24502025-03-21
08436046003699SEDECALODYSSEY+24202025-03-21
08436046003705SEDECALODYSSEY+24322025-03-21
08436046003712SEDECALODYSSEY+24402025-03-21
08436046003729SEDECALODYSSEY+24502025-03-21
08436046001404SEDECALHERCULES-322016-10-31
08436046001411SEDECALHERCULES-402016-10-31
08436046001428SEDECALHERCULES-502016-10-31
08436046001435SEDECALHERCULES-652016-10-31
08436046001442SEDECALHERCULES-802016-10-31
08436046001572SEDECALSM-20HF-B-D-T2016-10-28
08436046001589SEDECALSM-32HF-B-D-T2016-10-28
08436046001596SEDECALSM-40HF-B-D-T2016-10-28
08436046001602SEDECALSM-50HF-B-D-T2016-10-28
08436046002166SEDECALSM-40HF-B-D-VIR2016-10-31
08436046002173SEDECALMobileDiagnost wDR2016-10-31
08436046002296SEDECALProteus XR/f ST2017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00860008892768Foot and Ankle StandOXOS Medical, Inc.IYB2025-06-02
08800011103088DRGEMDRGEM CorporationIYB2024-10-24
08800011103095DRGEMDRGEM CorporationIYB2024-10-24
08800011103125DRGEMDRGEM CorporationIYB2024-10-24
08800011103132DRGEMDRGEM CorporationIYB2024-10-24
08800011103163DRGEMDRGEM CorporationIYB2024-10-24
08800011103170DRGEMDRGEM CorporationIYB2024-10-24
08809832900258SD-3100SHINYOUNG FOR M CO.,LTD.IYB2024-04-04
B884SVMS4000VMS 400Pausch, L.L.C.IYB2024-02-16
08809832900074LSS-2000SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900098SST-3100SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900104SST-3001SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900227SS-2100SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900234SS-2100SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
05999116100269F100 TS99N TUBE MOUNTCONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIYB2023-08-15
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D678A63301Provecta HD 16" Center to Center Wall Mounting PlateAIR TECHNIQUES, INC.IYB2023-07-11
D678A63361Provecta HD Single Post Mounting PlateAIR TECHNIQUES, INC.IYB2023-07-11
B884S10000110R0Paxis 100 AutoPausch, L.L.C.IYB2023-05-12
S10000110R0Paxis 100 AutoPausch, L.L.C.IYB2023-05-03
B884S10000110L0Paxis 100 AutoPausch, L.L.C.IYB2023-05-03
B884S04201000L0CirrusPausch, L.L.C.IYB2022-12-23
B884S04201000R0CirrusPausch, L.L.C.IYB2022-12-23
B884S100002000Paxis 200Pausch, L.L.C.IYB2022-12-23
B884S10000100L0Paxis 100Pausch, L.L.C.IYB2022-12-06
B884S10000100R0Paxis 100Pausch, L.L.C.IYB2022-12-06