IVD 2 11370000Z

GUDID B01611370000Z0

Solid-state-semiconductor radiation measuring probe

Primary Device ID	B01611370000Z0
NIH Device Record Key	099589d8-0d95-4585-b5b6-baed83ab9e6b
Commercial Distribution Status	In Commercial Distribution
Brand Name	IVD 2
Version Model Number	11370000Z
Catalog Number	11370000Z
Company DUNS	122240021
Company Name	SUN NUCLEAR CORP.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Special Storage Condition, Specify	Between 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 Temperature	Between -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 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 Temperature	Between -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Issuing Agency	Device ID
HIBCC	B01611370000Z0 [Primary]

IYE	Accelerator, Linear, Medical

Steralize Prior To Use	false
Device Is Sterile	false

B01611370000Z0	Radiation therapy QA device.
05060608880058	Radiation therapy QA device.