rf-IVD 2 11360000Z

GUDID B01611360000Z0

Radiation therapy QA device.

SUN NUCLEAR CORP.

Solid-state-semiconductor radiation measuring probe
Primary Device IDB01611360000Z0
NIH Device Record Key2beeaa61-4bea-4db3-a5b8-e8dfc407f57a
Commercial Distribution StatusIn Commercial Distribution
Brand Namerf-IVD 2
Version Model Number11360000Z
Catalog Number11360000Z
Company DUNS122240021
Company NameSUN NUCLEAR CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the IVD system components in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation is kept at a minimum.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the IVD system components in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation is kept at a minimum.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB01611360000Z0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-14

On-Brand Devices [rf-IVD 2]

B01611360000Z0Radiation therapy QA device.
05060608880041Radiation therapy QA device.

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