6-12 MV ISORAD Detector, (1.5m Cable) 11630006Z

GUDID B01611630006Z0

Radiation therapy QA device.

SUN NUCLEAR CORP.

Solid-state-semiconductor radiation measuring probe
Primary Device IDB01611630006Z0
NIH Device Record Key572e2e00-3172-479c-9216-e385f4f996b5
Commercial Distribution Discontinuation2019-06-18
Commercial Distribution StatusNot in Commercial Distribution
Brand Name6-12 MV ISORAD Detector, (1.5m Cable)
Version Model Number11630006Z
Catalog Number11630006Z
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
GS105060608880560 [Primary]
HIBCCB01611630006Z0 [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

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