SEDECAL

GUDID 08436046002937

Stationary diagnostic x-ray table

SEDECAL

Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered
Primary Device ID08436046002937
NIH Device Record Key26e79187-f0da-49c5-a9da-6bcb469194c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSEDECAL
Version Model NumberMULT-FWFTTD
Company DUNS510948979
Company NameSEDECAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]
GS108436046002937 [Primary]

FDA Product Code

IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top
IXQTable, Radiographic, Stationary Top

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-23
Device Publish Date2021-02-15

On-Brand Devices [SEDECAL]

08436046002364Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002494Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002487Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002470Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002463Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002456Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002449Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002432Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002609This mobile digital radiographic system is intended for use by a qualified/trained doctor or tec
08436046002593This mobile digital radiographic system is intended for use by a qualified/trained doctor or tec
08436046002586This mobile digital radiographic system is intended for use by a qualified/trained doctor or tec
08436046002579This mobile digital radiographic system is intended for use by a qualified/trained doctor or tec
08436046002517The SEDECAL X PLUS LP PLUS Radiographic Systems with (or without) Digital Detector are intended
08436046002500The SEDECAL X URS Radiographic System is intended for use by a qualified/trained doctor or techn
08436046002562Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002555Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002548Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002531Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject
08436046002388The CHALLENGEX AP Radiographic System is intended for use by a qualified/trained doctor or tech
08436046003033The Proteus XR/f ET Radiographic Systems with (or without) Digital Detector are intended for use
08436046003026The Proteus XR/f ST Radiographic Systems with (or without) Digital Detector are intended for use
08436046002937Stationary diagnostic x-ray table

Trademark Results [SEDECAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SEDECAL
SEDECAL
74630773 not registered Dead/Abandoned
SEDECAL, S.A.
1995-02-06

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