DEVICE: Flex small 4 MR coil set 3T (04056869014524)
Device Identifier (DI) Information
Flex small 4 MR coil set 3T
08626876
In Commercial Distribution
Siemens Healthcare GmbH
08626876
In Commercial Distribution
Siemens Healthcare GmbH
Contains Medical Device Mat. 8625779 (GTIN:04056869014395)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Full-body MRI system, superconducting magnet | A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OUO | Tomographic imager combining emission computed tomography with nuclear magnetic resonance |
LNH | System, nuclear magnetic resonance imaging |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K121434 | 000 |
K133226 | 000 |
K151579 | 000 |
K153343 | 000 |
K170396 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4cfe92c1-922c-4410-a304-6273dfed2883
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