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.
04056869049571
GS1

1
544891302 *Terms of Use
Contains Medical Device Mat. 8635505 (GTIN:04056869038766)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LNH System, nuclear magnetic resonance imaging
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K041111 000
K043030 000
K082331 000
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

9bb0b768-9976-4966-9ae3-771a93a64eb9
November 17, 2021
4
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)888-7436
CONTACT@SIEMENS-HEALTHINEERS.COM
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