AccessGUDID - DEVICE: Flex large 4 MR coil set 1.5T (04056869014616)

GUDID

Device Identifier (DI) Information

Brand Name: Flex large 4 MR coil set 1.5T
Version or Model: 10185502
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Siemens Healthcare GmbH

Primary DI Number: 04056869014616
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.10185552 (GTIN:04056869014784)

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37654	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNH	System, nuclear magnetic resonance imaging
MOS	Coil, magnetic resonance, specialty
LNI	System, nuclear magnetic resonance spectroscopic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121434	000
K123938	000
K151579	000
K153343	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: f0db2a35-798b-4aaf-ab5e-7f967ba8ecc5
Public Version Date: November 17, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2016