Precision Cut EBT3 GafChromic™ Film

GUDID 05060608881178

Precision Cut EBT3 GafChromic™ Film

SUN NUCLEAR CORP.

Medical x-ray film, non-screen
Primary Device ID05060608881178
NIH Device Record Key241534ad-c657-4676-84ff-ffe60f8f35e8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Cut EBT3 GafChromic™ Film
Version Model Number158200
Company DUNS122240021
Company NameSUN NUCLEAR CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060608881178 [Primary]

FDA Product Code

IWZFilm, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-10
Device Publish Date2024-01-02

Devices Manufactured by SUN NUCLEAR CORP.

05060608881512 - Precision Cut GafChromic™ Film2024-11-11 Radiographic film
05060608881178 - Precision Cut EBT3 GafChromic™ Film2024-01-10Precision Cut EBT3 GafChromic™ Film
05060608881178 - Precision Cut EBT3 GafChromic™ Film2024-01-10 Precision Cut EBT3 GafChromic™ Film
05060608881123 - SunSCAN 3D2023-06-16 The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commis
05060608881130 - SunSCAN 3D2023-06-16 The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commis
05060608880041 - rf-IVD 22020-08-03 Radiation therapy QA device.
05060608880874 - PlanIQ2020-08-03 Radiation therapy QA software.
05060608880102 - StereoPHAN2020-07-31 Radiation therapy, machine QA device
05060608880751 - IC PROFILER2020-07-31 Radiation therapy QA device.

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