15-25 MV ISORAD Detector (3m Cable) 11640003Z

GUDID B01611640003Z0

Radiation therapy QA device.

SUN NUCLEAR CORP.

Solid-state-semiconductor radiation measuring probe
Primary Device IDB01611640003Z0
NIH Device Record Key0686751b-a02d-4cb8-8fa4-d56ddba289f8
Commercial Distribution Discontinuation2019-06-18
Commercial Distribution StatusNot in Commercial Distribution
Brand Name15-25 MV ISORAD Detector (3m Cable)
Version Model Number11640003Z
Catalog Number11640003Z
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

Special Storage Condition, SpecifyBetween 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *When shipping a detector, always pack in a shipping container designed for fragile objects.

Device Identifiers

Device Issuing AgencyDevice ID
GS105060608880584 [Primary]
HIBCCB01611640003Z0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IWBSystem, Radiation Therapy, Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-18
Device Publish Date2017-01-14

On-Brand Devices [15-25 MV ISORAD Detector (3m Cable)]

B01611640003Z0Radiation therapy QA device.
B01611640002Z0Radiation therapy QA device.

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