AccessGUDID - DEVICE: Body Spine Array M MR Coil Kit (04056869049670)

GUDID

Device Identifier (DI) Information

Brand Name: Body Spine Array M MR Coil Kit
Version or Model: 10019288
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Siemens Shenzhen Magnetic Resonance Ltd.

Primary DI Number: 04056869049670
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544891302 *Terms of Use

Device Description: Contains Medical Device Mat. 8635539 (GTIN:04056869038773)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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
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.

GMDN Preferred Term Name

GMDN Definition

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.

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 470cf507-e739-46a4-9ffd-e9faf57186aa
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016