FDA.reportPublic FDA data

SEDECAL

Primary DI
08436046002104
Brand
SEDECAL
Company
SEDECAL
Model
NET 4000-AT
Device description
Elevating radiological table
Published
2016-10-31
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
KXJTable, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXJTable, RadiologicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436046002104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436046002104084360460021048436046002104

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.

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 Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

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
Primary DIBrandCompanyProduct codePublished
00198953081839NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953081877NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953089835NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00198953089842NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00887761943209PadsBaxter Medical Systems GmbH + Co. KGKXJ2025-01-20
00887761966673Carbon Pelvic systemBaxter Medical Systems GmbH + Co. KGKXJ2025-01-17
00857534006691ORT400 TableIMRIS Imaging, Inc.KXJ2024-10-04
00857534006738ORT200IMRIS Imaging, Inc.KXJ2024-10-04
00887761967977Hillrom™Baxter Medical Systems GmbH + Co. KGKXJ2024-02-22
00887761967984Hillrom™Baxter Medical Systems GmbH + Co. KGKXJ2024-02-22
00810050245487NADOMICO MED-DEVICE, LLCKXJ2023-05-01
00810050245463NADOMICO MED-DEVICE, LLCKXJ2023-01-13
00887761968424TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761969414PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761967632X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967649X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967656X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967717Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967724Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967731Back SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967762Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967786Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967809Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967847Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967854Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967861Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967885PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967892PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967915PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967939PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03