AccessGUDID - DEVICE: Philips (06970564410369)

GUDID

Device Identifier (DI) Information

Brand Name: Philips
Version or Model: 4522-133-17162
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shanghai Chenguang Medical Technologies Co., Ltd

Primary DI Number: 06970564410369
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 545297822 *Terms of Use

Device Description: SENSE FLEX M COIL 1.5T

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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
Radio-frequency MRI system coil	A radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This GMDN code includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.

GMDN Preferred Term Name

GMDN Definition

Radio-frequency MRI system coil

A radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This GMDN code includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.

FDA Product Code

[?]

Product Code	Product Code Name
MOS	Coil, Magnetic Resonance, Specialty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052013	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: 35a73083-fd59-4aad-9560-9231e48bd74f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016