Vareximaging

GUDID 08718755001419

x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator) This is a device of the Optica 40 series.

Varex Imaging Nederland B.V.

Automatic-aperture-control diagnostic x-ray system collimator Automatic-aperture-control diagnostic x-ray system collimator Automatic-aperture-control diagnostic x-ray system collimator Automatic-aperture-control diagnostic x-ray system collimator Automatic-aperture-control diagnostic x-ray system collimator Automatic-aperture-control diagnostic x-ray system collimator Automatic-aperture-control diagnostic x-ray system collimator Automatic-aperture-control diagnostic x-ray system collimator Automatic-aperture-control diagnostic x-ray system collimator Automatic-aperture-control diagnostic x-ray system collimator Automatic-aperture-control diagnostic x-ray system collimator Automatic-aperture-control diagnostic x-ray system collimator Automatic-aperture-control diagnostic x-ray system collimator
Primary Device ID08718755001419
NIH Device Record Keye4cda9cb-d30a-4294-8b70-0a080ca2f7ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameVareximaging
Version Model Number50126-20-OEM
Company DUNS413223942
Company NameVarex Imaging Nederland B.V.
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108718755001419 [Primary]

FDA Product Code

IZWCollimator, Automatic, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-22
Device Publish Date2019-07-12

Devices Manufactured by Varex Imaging Nederland B.V.

08718755004052 - Varex Imaging2022-10-03 x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bea
08718755004069 - Varex Imaging2022-10-03 x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bea
08718755003208 - Varex Imaging2022-04-12 x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bea
08718755003215 - Varex Imaging2022-04-12 x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bea
08718755003222 - Varex Imaging2022-04-12 x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bea
08718755003239 - Varex Imaging2022-04-12 x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bea
08718755003246 - Varex Imaging2022-04-12 x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bea
08718755003253 - Varex Imaging2022-04-12 x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bea

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