FDA.reportPublic FDA data

RINN®

Primary DI
D6475408531
Brand
RINN®
Company
Dentsply International Inc.
Model
540853
Device description
UNIVERSAL COLLIMATOR
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZXCollimator, manual, radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZXCollimator, Manual, RadiographicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6475408531PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray system collimatorA beam restriction device used in dental x-ray systems to determine the dimension and direction of the x-ray beam, limiting the effects of scattered radiation. It is used to control the size and shape of the x-ray beam reaching the patient's oral cavity and the film or image receptor. It includes all kinds of x-ray beam restriction devices used in diagnostic dental x-ray systems, such as cones and slit collimators. The device is typically designed for use with a specific dental x-ray system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-8825xx@xx.xx

Regulatory Flags#

DUNS number
795572718
Device count
1
Lot or batch
true
Manufacturing date on label
true

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D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975501940459iRayiRay Imaging Technology (Haining) LimitedIZX2025-07-02
06975501940411iRayiRay Imaging Technology (Haining) LimitedIZX2024-12-16
06975501940428iRayiRay Imaging Technology (Haining) LimitedIZX2024-12-16
08718755004052Varex ImagingVarex Imaging Nederland B.V.IZX2022-09-23
08718755004069Varex ImagingVarex Imaging Nederland B.V.IZX2022-09-23
08718755003208Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003215Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003222Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003239Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003246Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003253Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003260Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003277Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003284Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003291Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003307Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003314Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003321Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003338Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003345Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003352Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003369Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003376Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003383Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003390Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003406Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003413Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003420Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003437Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755001969Varex ImagingVarex Imaging Nederland B.V.IZX2022-02-07