FDA.reportPublic FDA data

Dunlee

Primary DI
00884838085381
Brand
Dunlee
Company
Dunlee Corporation
Model
CTR2150
Catalog number
4598-012-21881
Device description
X-Ray Tube Housing Assembly
Published
2017-03-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITYAssembly, tube housing, x-ray, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITYAssembly, Tube Housing, X-Ray, DiagnosticRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838085381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838085381008848380853818848380853810884838085381

GMDN Terms#

Term, Definition table
TermDefinition
X-ray tube housing assembly, diagnosticA metallic (e.g., steel, aluminium alloy) case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes sheet lead surrounds at appropriate locations to shield unwanted x-ray radiation and collimators near the aperture; it is usually filled with oil to prevent electrical arcs from the high-voltage components of the x-ray tube. The housing also includes attachment points, cooling means, high-voltage cables, and supports for the tube and cable receptacles. It may be an independent unit mounted in a tube support, or under a fluoroscopic table as a component of a radiographic system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078715368
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
00884838069725DunleeCTR2150CEAN4598-002-532712017-07-01
00884838069732DunleeCTR1742CEAN4598-003-020912017-07-01
00884838069749DunleeCTR1742CEAN4598-003-429612017-07-01
00884838069756DunleeCTR2150CEUH4598-003-024412017-07-01
00884838069763DunleeCTR17354598-005-942912017-07-01
00884838069770DunleeCTR2280CESV4598-006-492112017-07-01
00884838069787DunleeCTR2280CESV4598-006-492212017-07-01
00884838069893DunleeDA135CT/e9896-055-808002017-07-01
00884838069909DunleeMX135CT/e9896-055-808012017-07-01
00884838069923DunleeDA1659896-055-826002017-07-01
00884838069930DunleeMX165PS9896-055-829002017-07-01
00884838069947DunleeDA165PS9896-055-829012017-07-01
00884838069954DunleeMX165NP9896-055-839002017-07-01
00884838069961DunleeDA165NP9896-055-839012017-07-01
00884838069978DunleeDA165NP9896-055-826072017-07-01
00884838070080DunleeDA240SHIM9896-055-866012017-07-01
00884838070097DunleeDA240TOSH9896-055-866022017-07-01
00884838070127DunleeDA200ULTRA9896-055-887042017-07-01
00884838070134DunleeDA200P404598-006-534512017-07-01
00884838070219PhilipsCTR21129896-055-924002017-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10850012223136Chronos Imaging LLCCHRONOS IMAGING LLCITY2025-10-31
00195278723963NAGE Healthcare Japan CorporationITY2025-10-15
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06971564630153RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-08-11
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00884838127517CT XS Tube CPOPhilips Medical Systems DMC GmbHITY2025-07-31
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06971564631396RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-04-24
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04580274412373Rotating Anode X-ray Tube AssemblyCANON ELECTRON TUBES & DEVICES CO. LTD.ITY2025-03-14
06971564631198RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-01-22
00195278770271VolusonGE Healthcare Austria GmbH & Co OGITY2025-01-07
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