FDA.reportPublic FDA data

Collimare

Primary DI
00862005000306
Brand
Collimare
Company
COLLIMARE, LLC
Model
CML-150-0001-C
Device description
Collimator, Manual Certified, 150kVp, LED 25W
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZXCollimator, Manual, Radiographic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073124000COLLIMARE COLLIMATOR FAMILYCollimare, LLC2007-11-16IZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862005000306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862005000306008620050003068620050003060862005000306

GMDN Terms#

Term, Definition table
TermDefinition
Manual-aperture-control diagnostic x-ray system collimator, non-motorizedA standard, non-motorized, diagnostic x-ray beam-limiting device whose aperture size/length/shutter assembly must be manually adjusted in order to match the size of the x-ray beam to the size of the x-ray cassette in use. It includes designs with manual controls that operate one or more shutter pairs and also designs that require the addition or removal of attachments or extensions that allow the operator to alter the size and shape of the exit beam from a cone or cylinder. An x-ray collimator is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius55 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3038097184howard@collimare.com

Regulatory Flags#

DUNS number
626743954
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862005000313CollimareCML-125-0001-C2016-09-28
00862005000320CollimareCPL-125-0001-C2016-09-28
00862005000337CollimareCPL-125-SR01-C2016-09-28
00862005000344CollimareCPL-125-MX01-C2016-09-28
00862005000351CollimareCML-150-CMR1-C2016-09-28
00862005000368CollimareCTL-150-0001-C2016-09-28

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