FDA.reportPublic FDA data

SNC350p (BNC)

Primary DI
05060608880126
Brand
SNC350p (BNC)
Company
SUN NUCLEAR CORP.
Model
1045300Z
Catalog number
1045000-0Z
Device description
Radiation therapy QA device.
Published
2019-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LHNSystem, Radiation Therapy, Charged-Particle, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112981000SUN 125C IONIZATION CHAMBERSun Nuclear Corp.2012-01-25LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B01610450000Z0PreviousHIBCC0
05060608880126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060608880126050606088801265060608880126

GMDN Terms#

Term, Definition table
TermDefinition
Solid-state-semiconductor radiation measuring probeA device covering a variety of radiation detector probe designs incorporating a solid-state semiconductor serving as an ionization chamber. It is used as a component of a survey meter or analytical instrument used for radiation detection and measurement. It is typically used to detect low amounts of radioactivity and its energy discrimination properties allow it to be incorporated in radiation detection, measurement instruments and radiation spectroscopy systems. The composition and impurities in the semiconductor material used determine its energy discrimination capabilities and the kind of radiation (x-ray, gamma ray, high-energy beta particles or neutrons) that can be detected.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure18.7 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Special Storage Condition, Specify00If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, Specify00Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, Specify00Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Special Storage Condition, Specify00Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, Specify00The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Storage Environment Atmospheric Pressure57.2 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122240021
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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