DEVICE: Collimare (00862005000306)
Device Identifier (DI) Information
Collimare
CML-150-0001-C
In Commercial Distribution
COLLIMARE, LLC
CML-150-0001-C
In Commercial Distribution
COLLIMARE, LLC
Collimator, Manual Certified, 150kVp, LED 25W
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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42253 | Manual-aperture-control diagnostic x-ray system collimator, non-motorized |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IZX | Collimator, Manual, Radiographic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K073124 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -25 and 55 Degrees Celsius |
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Handling Environment Temperature: between -25 and 55 Degrees Celsius |
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
53131297-754e-4684-bffa-76b4616b1acf
July 06, 2018
3
September 28, 2016
July 06, 2018
3
September 28, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
3038097184
howard@collimare.com
howard@collimare.com