FDA.report

0.6/1.2P326D-150

Primary DI
04540217062256
Brand
0.6/1.2P326D-150
Company
SHIMADZU CORPORATION
Model
582-50300-50
Published
2020-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ITYAssembly, Tube Housing, X-Ray, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
ITYAssembly, Tube Housing, X-Ray, DiagnosticRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04540217062256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04540217062256045402170622564540217062256

GMDN Terms

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

Regulatory Flags

DUNS number
690558747
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

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