DEVICE: Body Spine Array XXL MR Coil Kit (04056869049571)
Device Identifier (DI) Information
Body Spine Array XXL MR Coil Kit
10019202
In Commercial Distribution
Siemens Shenzhen Magnetic Resonance Ltd.
10019202
In Commercial Distribution
Siemens Shenzhen Magnetic Resonance Ltd.
Contains Medical Device Mat. 8635505 (GTIN:04056869038766)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
37652 | Full-body MRI system, permanent magnet |
A general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body. It includes a permanent magnet assembly and can be fixed-location, mobile, or transportable. In addition to producing conventional MR images, it can be designed or modified through additional software/hardware to perform MR spectroscopy and other real-time imaging procedures necessary for physiologically gated imaging procedures, or MRI mammography and other MRI guided interventional, therapeutic, or surgical applications. It is available in a variety of gantry configurations including closed bore, open bore, open-sided or other patient accessible designs.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LNH | System, nuclear magnetic resonance imaging |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K041111 | 000 |
K043030 | 000 |
K082331 | 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
9bb0b768-9976-4966-9ae3-771a93a64eb9
November 17, 2021
4
September 24, 2016
November 17, 2021
4
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
CONTACT@SIEMENS-HEALTHINEERS.COM
CONTACT@SIEMENS-HEALTHINEERS.COM