DEVICE: Pin Hole Collimator Asm Symbia (04056869002033)
Device Identifier (DI) Information
Pin Hole Collimator Asm Symbia
07332039
In Commercial Distribution
7332039..
SIEMENS MEDICAL SOLUTIONS USA, INC.
07332039
In Commercial Distribution
7332039..
SIEMENS MEDICAL SOLUTIONS USA, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Multi-hole nuclear medicine system collimator, low-energy | A device designed specifically for use in diagnostic nuclear medicine imaging applications operating with an energy range of less than 500 kilo-electronvolt (keV). It consists of an array of small openings drilled or cast into a flat sheet or plate of lead or lead-equivalent materials. Its size and shape is intended to conform to the crystal shape of a nuclear medicine imaging system to ensure that only gamma ray activity directly in front of the individual collimator channels reaches the scintillation. It has attachment mechanisms that enable it to be safely transported, removed from, and attached to the detector head of the system. |
FDA Product Code
[?]Product Code | Product Code Name |
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KPS | System, tomography, computed, emission |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K142006 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between -20 and 49 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Temperature: between -20 and 49 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
46f02dba-3a59-4602-b5f8-0dd7ace5b168
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 24, 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
[?]
+1(800)888-7436
XX@XX.XX
XX@XX.XX