AccessGUDID - DEVICE: Flex small 4 MR coil set 3T (04056869014524)

GUDID

Device Identifier (DI) Information

Brand Name: Flex small 4 MR coil set 3T
Version or Model: 08626876
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Siemens Healthcare GmbH

Primary DI Number: 04056869014524
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313217003 *Terms of Use

Device Description: Contains Medical Device Mat. 8625779 (GTIN:04056869014395)

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

[?]

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.

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

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: 4cfe92c1-922c-4410-a304-6273dfed2883
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016