DEVICE: Collimator AL02 II eL (04056869011578)

Device Identifier (DI) Information

Collimator AL02 II eL
10092614
In Commercial Distribution

Siemens Healthcare GmbH
04056869011578
GS1

1
313217003 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Manual-aperture-control diagnostic x-ray system collimator, motorized A standard, diagnostic x-ray beam-limiting and shaping device with a motorized shutter/length adjustment mechanism that requires the operator to manually adjust the collimator shutters or length of the cone prior to an exposure in order to match the size and shape of the x-ray beam to the size of the x-ray cassette in use. Most motorized collimator assemblies include a light-centring device. 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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FDA Product Code

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Product Code Product Code Name
KPW Device, beam limiting, x-ray, diagnostic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 20 and 75 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -40 and 70 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

8b02821a-9df7-4e77-af6e-c11701c2b959
March 29, 2018
2
October 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)888-7436
XX@XX.XX
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