FDA.reportPublic FDA data

Dunlee

Primary DI
00884838085404
Brand
Dunlee
Company
Dunlee Corporation
Model
CTR2150
Catalog number
4598-013-01601
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
Rx
false
OTC
false
Sterile
false
Single use
false

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
00884838085404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838085404008848380854048848380854040884838085404

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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00195278723963NAGE Healthcare Japan CorporationITY2025-10-15
06971564631563RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-08-30
06971564630153RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-08-11
06971564630160RADIIHangzhou 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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